A Study in Adult Patients With Type I, III or IV Osteogen... | NCT03118570 | Trialant
NCT03118570
Sponsor
Ultragenyx Pharmaceutical Inc
Status
Completed
Last Update Posted
Jul 5, 2023Actual
Enrollment
112Actual
Phase
Phase 2
Conditions
Osteogenesis Imperfecta, Type I
Osteogenesis Imperfecta Type III
Osteogenesis Imperfecta Type IV
Interventions
setrusumab
Calcium
Vitamin D
zoledronic acid (optional)
Countries
United States
Canada
Denmark
France
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03118570
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MBPS205
Secondary IDs
ID
Type
Description
Link
2016-005096-27
EudraCT Number
Brief Title
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Official Title
A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)
Acronym
Asteroid
Organization
Ultragenyx Pharmaceutical IncINDUSTRY
Status Module
Record Verification Date
Feb 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 11, 2017Actual
Primary Completion Date
Oct 1, 2019Actual
Completion Date
Nov 12, 2020Actual
First Submitted Date
Apr 3, 2017
First Submission Date that Met QC Criteria
Apr 13, 2017
First Posted Date
Apr 18, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Dec 13, 2021
Results First Submitted that Met QC Criteria
Feb 7, 2022
Results First Posted Date
Mar 2, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 29, 2023
Last Update Posted Date
Jul 5, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Ultragenyx Pharmaceutical IncINDUSTRY
Collaborators
Name
Class
Mereo BioPharma
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.
Detailed Description
This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.
Conditions Module
Conditions
Osteogenesis Imperfecta, Type I
Osteogenesis Imperfecta Type III
Osteogenesis Imperfecta Type IV
Keywords
Osteogenesis Imperfecta
Brittle Bone Disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
112Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Setrusumab 20 mg/kg (Blinded)
Experimental
Setrusumab 20 mg/kg intravenous (IV) infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Drug: setrusumab
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Drug: zoledronic acid (optional)
Setrusumab 8 mg/kg (Blinded)
Experimental
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Drug: setrusumab
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Drug: zoledronic acid (optional)
Setrusumab 2 mg/kg (Blinded)
Experimental
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Drug: setrusumab
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Drug: zoledronic acid (optional)
Setrusumab 20 mg/kg (Open-Label)
Experimental
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Drug: setrusumab
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Drug: zoledronic acid (optional)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
setrusumab
Drug
Intravenous infusion
Setrusumab 2 mg/kg (Blinded)
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 8 mg/kg (Blinded)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Radial Trabecular Volumetric Bone Mineral Density (Tr vBMD) at Month 12
Assessed by high resolution peripheral quantitative computed tomography (HRpQCT). HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presents the ratio of the means between the visit and Baseline from analysis of covariance (ANCOVA).
Baseline, Month 12 (end of treatment [EOT])
Change From Baseline in Radial Bone Strength (Failure Load) at Month 12
Assessed by finite element analysis (FEA) of models generated from HRpQCT images of the distal radius.
Baseline, Month 12 (EOT)
Change From Baseline in Radial Bone Strength (Stiffness) at Month 12
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Month 12 (EOT)
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Radial and Tibial Tr VBMD Over Time: Full Analysis Set
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Baseline, Months 6, 12 (EOT), 18, 24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients with a clinical diagnosis of OI Type I, III or IV with a confirmed defect in the COL1A1/COL1A2 genes, as confirmed by genetic testing
One or more fractures in the past 5 years
Capable of giving signed consent
Exclusion Criteria:
History of skeletal malignancies or other bone diseases (other than OI)
History of neural foraminal stenosis (except if due to scoliosis)
History of myocardial infarction, angina pectoris, ischaemic stroke or transient ischaemic attack
History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
Treatment with bisphosphonates within 3 months of randomisation
Treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications within 6 months of randomisation
Glorieux FH, Langdahl B, Chapurlat R, De Beur SJ, Sutton VR, Poole KES, Dahir KM, Orwoll ES, Willie BM, Mikolajewicz N, Zimmermann E, Hosseinitabatabaei S, Ominsky MS, Saville C, Clancy J, MacKinnon A, Mistry A, Javaid MK. Setrusumab for the treatment of osteogenesis imperfecta: 12-month results from the phase 2b asteroid study. J Bone Miner Res. 2024 Sep 2;39(9):1215-1228. doi: 10.1093/jbmr/zjae112.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants were randomized 1:1:1:1 to 3 doses of setrusumab (20 mg/kg, 8 mg/kg and 2 mg/kg) and placebo for a 12-month Treatment Period. Per Protocol Amendment 4, participants originally randomized to the placebo group were reassigned to receive 20 mg/kg open-label setrusumab (1 discontinued study prior to the transition). Two participants in the setrusumab 20 mg/kg open-label group were randomized into this group after Amendment 4 and did not receive placebo.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg intravenous (IV) infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
FG001
Setrusumab 8 mg/kg (Blinded)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 19, 2019
Dec 13, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blind, Dose-finding Study, incorporating an open-label substudy
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Sponsor will be masked until the primary analysis of the study except for open-label substudy treatment arm. The study site pharmacist will be unmasked to treatment allocation throughout. Study treatment will be monitored by a separate unmasked monitoring team.
Who Masked
ParticipantInvestigator
Placebo
Placebo Comparator
Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
BPS804
Calcium
Dietary Supplement
tablets
Placebo
Setrusumab 2 mg/kg (Blinded)
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 8 mg/kg (Blinded)
Vitamin D
Dietary Supplement
capsules
Placebo
Setrusumab 2 mg/kg (Blinded)
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 8 mg/kg (Blinded)
zoledronic acid (optional)
Drug
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Setrusumab 2 mg/kg (Blinded)
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 8 mg/kg (Blinded)
Changes From Baseline in Radial and Tibial Tr VBMD at Months 6 and 12: Open-Label Arm
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Baseline, Months 6, 12 (EOT)
Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) Over Time: Full Analysis Set
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Months 6, 12 (EOT), 18, 24
Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) at Months 6 and 12: Open-Label Arm
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Months 6, 12 (EOT)
Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) Over Time: Full Analysis Set
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Months 6, 12 (EOT), 18, 24
Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) at Months 6 and 12: Open-Label Arm
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Months 6, 12 (EOT)
Percentage of Participants With at Least 1 New Fracture (Peripheral, Vertebral, Long-Bone, Any) at Month 12
Fracture assessment, confirmed by central radiographic reading, was carried out for peripheral including all major long bones, minor bone (digits, ribs) and vertebral fractures. Fractures without clinical symptoms, detected only by means of radiographic investigations, were not included in the analysis.
Month 12 (EOT)
Change From Baseline in Lumbar, Total Body, and Femoral Neck Bone Mineral Density (BMD) T-score at Month 6
BMD was evaluated by dual-energy x-ray absorptiometry (DXA). T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD.
Baseline, Month 6
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 6
BMD was evaluated by DXA.
Baseline, Month 6
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD T-score at Month 12
BMD was evaluated by DXA. T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD.
Baseline, Month 12 (EOT)
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 12
BMD was evaluated by DXA.
Baseline, Month 12 (EOT)
Change From Baseline in Total vBMD (Radial and Tibial) Over Time
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Baseline, Months 6, 12 (EOT), 18, and 24
Change From Baseline in Cortical vBMD (Radial and Tibial) Over Time
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Baseline, Months 6, 12 (EOT), 18, and 24
Number of Participants With Clinically Significant Changes From Baseline in Body Height, Weight and Body Mass Index (BMI) at 6 and 12 Months: Full Analysis Set
Baseline, Month 6, Month 12 (EOT)
Change From Baseline in Lean and Fat Body Mass From Whole Body at Months 6 and 12
Lean and fat body mass was evaluated using whole body DXA (including the head).
Baseline, Months 6, 12 (EOT)
Change From Baseline in Amino-Terminal Propeptide of Type 1 Procollagen (P1NP) up to Month 12
Baseline, Months 1, 3, 6, 9, 12 (EOT)
Change From Baseline in Carboxy-Terminal Telo-Peptide [CTX-1] up to Month 12
Baseline, Months 1, 3, 6, 9, 12 (EOT)
Change From Baseline in Short Form 12 Health Survey (SF-12) Physical Component Summary Score at Months 6 and 12
The SF-12 is a generic, 12-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these 8 domains and 2 summary measures of physical and mental health: The Physical Component Summary and the Mental Component Summary. The total score for the Physical Component Summary ranges from 0 to 100, where higher scores reflect better physical functioning.
Baseline, Months 6, 12 (EOT)
Change From Baseline in SF-12 Mental Component Summary Score at Months 6 and 12
The SF-12 is a generic, 12-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these 8 domains and 2 summary measures of physical and mental health: The Physical Component Summary and the Mental Component Summary. The total score for the Mental Component Summary ranges from 0 to 100, where higher scores reflect better mental health functioning.
Baseline, Months 6, 12 (EOT)
Change From Baseline in Index (Utility) Score on EuroQol 5-Dimension 5-Level Descriptive System (EQ-5D-5L) Score at Months 6 and 12
The EQ-5D-5L is a standardised measure of health status comprised of a descriptive system of 5 health-related quality of life states (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS) of overall health. Each dimension is rated on a 5-point response scale indicating severity of problems, where 1 is "no problems" and 5 is "extreme problems". The 5 questions are scored and together contribute to the EQ-5D index (utility) score between 0 and 1 (1 being perfect health).
Baseline, Months 6 and 12 (EOT)
Change From Baseline in Osteogenesis Imperfecta Specific Quality of Life Questionnaire for Adults (OIQoL-A) Total Score at Months 6 and 12
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The total score is calculated on a 0-100 scale, where higher scores indicate a greater (negative) impact on quality of life.
Baseline, Months 6, 12 (EOT)
Change From Baseline in OIQoL-A Pain Subscale Score at Months 6 and 12
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The Pain subscale ranges from 0 to 10, with higher value representing worse pain.
Baseline, Months 6, 12 (EOT)
Change From Baseline in OIQoL-A Activity Subscale Score at Months 6 and 12
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The Activities subscale ranges from 0 to 100, with higher value representing increased difficulty.
Baseline, Months 6, 12 (EOT)
Percentage of Participants Who Were Positive for Anti-Setrusumab Antibodies at Any Time During the Study up to Month 14
Serum samples were screened for antibodies binding to setrusumab using a validated assay method by or under the supervision of the sponsor.
up to Month 14
Percentage of Participants With Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation or Death
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; is another important medical event. The intensity for each AE was graded as mild, moderate or severe, according to the investigator's judgement. An event was considered related to study drug if there were a "reasonable possibility" of a relationship, according to the investigator's clinical judgment. A TEAE was defined as an event occurring or worsening on or after the first dose of study medication.
Non-serious AEs: up to Month 14; Serious AEs: up to Month 24. (Average duration of exposure to placebo was 5 months and for setrusumab was 11 month plus follow-up to 24 months.)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
FG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
FG003
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Participants were randomized to this group after amendment 4.
FG004
Placebo
Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Due to a protocol amendment, placebo was actually received for an average of 5 months. Participants originally randomized to the placebo group were reassigned to receive 20 mg/kg open-label setrusumab after amendment 4.
FG00031 subjects
FG00129 subjects
FG00230 subjects
FG0032 subjects
FG00420 subjects
Reassigned From Placebo to 20 mg/kg Open-Label Setrusumab
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00419 subjects
COMPLETED
FG00026 subjects
FG00122 subjects
FG00225 subjects
FG0032 subjects
FG00415 subjects
NOT COMPLETED
FG0005 subjects
FG0017 subjects
FG0025 subjects
FG0030 subjects
FG0045 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
Other, Not Specified
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
The 19 participants who transitioned from the Placebo arm to the Setrusumab 20 mg/kg Open-Label arm are NOT "double-counted" for this analysis.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
BG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
BG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
BG003
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
BG004
Placebo
Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Due to a protocol amendment, placebo was actually received for an average of 5 months.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00031
BG00129
BG00230
BG0032
BG00420
BG005112
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.6± 13.73
BG00140.4± 14.34
BG00247.2± 12.42
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00120
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG0002
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Radial Trabecular Volumetric Bone Mineral Density (Tr vBMD) at Month 12
Assessed by high resolution peripheral quantitative computed tomography (HRpQCT). HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presents the ratio of the means between the visit and Baseline from analysis of covariance (ANCOVA).
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment (per protocol almost all efficacy endpoints were to be analyzed only in the blinded treatment arms). Participants with an assessment at given time point.
Posted
Number
95% Confidence Interval
ratio
Baseline, Month 12 (end of treatment [EOT])
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Title
Measurements
OG0001.004(0.987 to 1.021)
OG0010.993(0.975 to 1.012)
OG0020.992(0.974 to 1.011)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
ANCOVA
0.644
Analysis is based on a log transformed analysis of covariance (ANCOVA) model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Primary
Change From Baseline in Radial Bone Strength (Failure Load) at Month 12
Assessed by finite element analysis (FEA) of models generated from HRpQCT images of the distal radius.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point.
Posted
Least Squares Mean
Standard Error
newton (N)
Baseline, Month 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Primary
Change From Baseline in Radial Bone Strength (Stiffness) at Month 12
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point.
Posted
Least Squares Mean
Standard Error
N/mm
Baseline, Month 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Secondary
Change From Baseline in Radial and Tibial Tr VBMD Over Time: Full Analysis Set
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point.
Posted
Number
95% Confidence Interval
ratio
Baseline, Months 6, 12 (EOT), 18, 24
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Changes From Baseline in Radial and Tibial Tr VBMD at Months 6 and 12: Open-Label Arm
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
All participants in the open-label arm who took at least 1 dose of study treatment. Participants with an assessment at given time point.
Posted
Number
95% Confidence Interval
ratio
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
OG000
Secondary
Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) Over Time: Full Analysis Set
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point.
Posted
Least Squares Mean
95% Confidence Interval
N
Baseline, Months 6, 12 (EOT), 18, 24
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) at Months 6 and 12: Open-Label Arm
Assessed by FEA of models generated from HRpQCT images of the distal radius.
All participants in the open-label arm who took at least 1 dose of study treatment. Participants with an assessment at given time point.
Posted
Least Squares Mean
95% Confidence Interval
N
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
OG000
Secondary
Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) Over Time: Full Analysis Set
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given time point.
Posted
Least Squares Mean
95% Confidence Interval
N/mm
Baseline, Months 6, 12 (EOT), 18, 24
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) at Months 6 and 12: Open-Label Arm
Assessed by FEA of models generated from HRpQCT images of the distal radius.
All participants in the open-label arm who took at least 1 dose of study treatment. Participants with an assessment at given time point.
Posted
Least Squares Mean
95% Confidence Interval
N/mm
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With at Least 1 New Fracture (Peripheral, Vertebral, Long-Bone, Any) at Month 12
Fracture assessment, confirmed by central radiographic reading, was carried out for peripheral including all major long bones, minor bone (digits, ribs) and vertebral fractures. Fractures without clinical symptoms, detected only by means of radiographic investigations, were not included in the analysis.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment.
Posted
Number
percentage of participants
Month 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Change From Baseline in Lumbar, Total Body, and Femoral Neck Bone Mineral Density (BMD) T-score at Month 6
BMD was evaluated by dual-energy x-ray absorptiometry (DXA). T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
T-score
Baseline, Month 6
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 6
BMD was evaluated by DXA.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
g/cm^2
Baseline, Month 6
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Secondary
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD T-score at Month 12
BMD was evaluated by DXA. T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
T-score
Baseline, Month 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 12
BMD was evaluated by DXA.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
g/cm^2
Baseline, Month 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Secondary
Change From Baseline in Total vBMD (Radial and Tibial) Over Time
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Number
95% Confidence Interval
ratio
Baseline, Months 6, 12 (EOT), 18, and 24
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Change From Baseline in Cortical vBMD (Radial and Tibial) Over Time
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Number
95% Confidence Interval
ratio
Baseline, Months 6, 12 (EOT), 18, and 24
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Number of Participants With Clinically Significant Changes From Baseline in Body Height, Weight and Body Mass Index (BMI) at 6 and 12 Months: Full Analysis Set
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Baseline, Month 6, Month 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
Secondary
Change From Baseline in Lean and Fat Body Mass From Whole Body at Months 6 and 12
Lean and fat body mass was evaluated using whole body DXA (including the head).
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
grams
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Secondary
Change From Baseline in Amino-Terminal Propeptide of Type 1 Procollagen (P1NP) up to Month 12
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
µg/L
Baseline, Months 1, 3, 6, 9, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
Secondary
Change From Baseline in Carboxy-Terminal Telo-Peptide [CTX-1] up to Month 12
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
µg/L
Baseline, Months 1, 3, 6, 9, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
Secondary
Change From Baseline in Short Form 12 Health Survey (SF-12) Physical Component Summary Score at Months 6 and 12
The SF-12 is a generic, 12-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these 8 domains and 2 summary measures of physical and mental health: The Physical Component Summary and the Mental Component Summary. The total score for the Physical Component Summary ranges from 0 to 100, where higher scores reflect better physical functioning.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Secondary
Change From Baseline in SF-12 Mental Component Summary Score at Months 6 and 12
The SF-12 is a generic, 12-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these 8 domains and 2 summary measures of physical and mental health: The Physical Component Summary and the Mental Component Summary. The total score for the Mental Component Summary ranges from 0 to 100, where higher scores reflect better mental health functioning.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Secondary
Change From Baseline in Index (Utility) Score on EuroQol 5-Dimension 5-Level Descriptive System (EQ-5D-5L) Score at Months 6 and 12
The EQ-5D-5L is a standardised measure of health status comprised of a descriptive system of 5 health-related quality of life states (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS) of overall health. Each dimension is rated on a 5-point response scale indicating severity of problems, where 1 is "no problems" and 5 is "extreme problems". The 5 questions are scored and together contribute to the EQ-5D index (utility) score between 0 and 1 (1 being perfect health).
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Months 6 and 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Secondary
Change From Baseline in Osteogenesis Imperfecta Specific Quality of Life Questionnaire for Adults (OIQoL-A) Total Score at Months 6 and 12
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The total score is calculated on a 0-100 scale, where higher scores indicate a greater (negative) impact on quality of life.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Change From Baseline in OIQoL-A Pain Subscale Score at Months 6 and 12
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The Pain subscale ranges from 0 to 10, with higher value representing worse pain.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Change From Baseline in OIQoL-A Activity Subscale Score at Months 6 and 12
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The Activities subscale ranges from 0 to 100, with higher value representing increased difficulty.
Full Analysis Set: all participants who are randomized to one of the blinded treatment arms and took at least 1 dose of study treatment. Participants with an assessment at given timepoint.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Months 6, 12 (EOT)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Secondary
Percentage of Participants Who Were Positive for Anti-Setrusumab Antibodies at Any Time During the Study up to Month 14
Serum samples were screened for antibodies binding to setrusumab using a validated assay method by or under the supervision of the sponsor.
Safety Population: all participants who received at least 1 dose of study drug. The 19 participants who transitioned from the Placebo arm to the Setrusumab 20 mg/kg Open-Label arm are reflected in both arms for this analysis.
Posted
Number
percentage of participants
up to Month 14
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG003
Secondary
Percentage of Participants With Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation or Death
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; is another important medical event. The intensity for each AE was graded as mild, moderate or severe, according to the investigator's judgement. An event was considered related to study drug if there were a "reasonable possibility" of a relationship, according to the investigator's clinical judgment. A TEAE was defined as an event occurring or worsening on or after the first dose of study medication.
Safety Population: all participants who received at least 1 dose of study drug. The 19 participants who transitioned from the Placebo arm to the Setrusumab 20 mg/kg Open-Label arm are reflected in both arms for this analysis.
Posted
Number
percentage of participants
Non-serious AEs: up to Month 14; Serious AEs: up to Month 24. (Average duration of exposure to placebo was 5 months and for setrusumab was 11 month plus follow-up to 24 months.)
ID
Title
Description
OG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG001
Time Frame
Non-serious AEs: up to Month 14; Serious AEs: up to Month 24. (Average duration of exposure to placebo was 5 months and for setrusumab was 11 month plus follow-up to 24 months.)
Description
Safety Population: all participants who received at least 1 dose of study drug. The 19 participants who transitioned from the Placebo arm to the Setrusumab 20 mg/kg Open-Label arm are reflected in both arms for this analysis.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
0
31
4
31
29
31
EG001
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
0
29
7
29
28
29
EG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
0
30
7
30
27
30
EG003
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
0
21
5
21
19
21
EG004
Placebo
Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
0
20
2
20
16
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Femur fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0021 affected30 at risk
EG0030 affected21 at risk
EG004
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Fracture of penis
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Ilium fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Joint abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Wound infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Neuritis
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Noninfective sialoadenitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Fracture nonunion
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Platybasia
Congenital, familial and genetic disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Chills
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0022 affected30 at risk
EG0032 affected21 at risk
EG0040 affected20 at risk
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0023 affected30 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Middle ear effusion
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Blepharospasm
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected31 at risk
EG0013 affected29 at risk
EG0022 affected30 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected29 at risk
EG0021 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected29 at risk
EG0025 affected30 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0011 affected29 at risk
EG0021 affected30 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected29 at risk
EG0027 affected30 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Injection site extravasation
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Pain
General disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0022 affected30 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected29 at risk
EG0022 affected30 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0022 affected30 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0005 affected31 at risk
EG0013 affected29 at risk
EG0024 affected30 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected29 at risk
EG0024 affected30 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0022 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0013 affected29 at risk
EG0022 affected30 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected29 at risk
EG0021 affected30 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0006 affected31 at risk
EG0014 affected29 at risk
EG0023 affected30 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0014 affected29 at risk
EG0023 affected30 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected29 at risk
EG0022 affected30 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0004 affected31 at risk
EG0013 affected29 at risk
EG0021 affected30 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0011 affected29 at risk
EG0022 affected30 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected29 at risk
EG0021 affected30 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0013 affected29 at risk
EG0023 affected30 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0012 affected29 at risk
EG0026 affected30 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Alanine aminotransferase abnormal
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Aspartate aminotransferase abnormal
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected29 at risk
EG0021 affected30 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0023 affected30 at risk
EG003
Lipase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0023 affected30 at risk
EG003
Vitamin D decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0022 affected30 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected29 at risk
EG0020 affected30 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG00015 affected31 at risk
EG0018 affected29 at risk
EG0029 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0006 affected31 at risk
EG0014 affected29 at risk
EG0028 affected30 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected31 at risk
EG0013 affected29 at risk
EG0024 affected30 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected29 at risk
EG0022 affected30 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected29 at risk
EG0023 affected30 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected29 at risk
EG0024 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0005 affected31 at risk
EG0015 affected29 at risk
EG0023 affected30 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected29 at risk
EG0023 affected30 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0004 affected31 at risk
EG0015 affected29 at risk
EG0026 affected30 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0003 affected31 at risk
EG0010 affected29 at risk
EG0021 affected30 at risk
EG003
Migraine
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0023 affected30 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0022 affected30 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected29 at risk
EG0020 affected30 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected29 at risk
EG0022 affected30 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected29 at risk
EG0022 affected30 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected29 at risk
EG0020 affected30 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected29 at risk
EG0022 affected30 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003095
Collagen Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000622723
setrusumab
D002118
Calcium
D014807
Vitamin D
D000077211
Zoledronic Acid
Ancestor Terms
ID
Term
D008673
Metals, Alkaline Earth
D004602
Elements
D007287
Inorganic Chemicals
D008670
Metals
D001779
Blood Coagulation Factors
D001685
Biological Factors
D012632
Secosteroids
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D004164
Diphosphonates
D063065
Organophosphonates
D009943
Organophosphorus Compounds
D009930
Organic Chemicals
D007093
Imidazoles
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
1 subjects
0 subjects
43.5
± 14.85
BG00440.9± 14.68
BG00542.4± 13.80
21
BG0031
BG00414
BG00573
Male
BG00014
BG0019
BG0029
BG0031
BG0046
BG00539
2
BG0030
BG0041
BG0057
Not Hispanic or Latino
BG00027
BG00127
BG00228
BG0032
BG00419
BG005103
Unknown or Not Reported
BG0001
BG0011
BG0020
BG0030
BG0040
BG0052
1
BG0030
BG0040
BG0054
White
Title
Measurements
BG00029
BG00127
BG00229
BG0032
BG00420
BG005107
Not Collected or Not Reported
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0040
BG0051
ANCOVA
0.485
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
ANCOVA
0.404
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00028
OG00122
OG00225
Title
Denominators
Categories
Title
Measurements
OG00061.25± 21.669
OG00132.25± 24.342
OG0028.86± 23.200
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
ANCOVA
0.006
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
ANCOVA
0.190
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
ANCOVA
0.704
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Participants
OG00028
OG00122
OG00225
Title
Denominators
Categories
Title
Measurements
OG0001638.70± 625.808
OG0011422.00± 703.275
OG002209.89± 671.777
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
ANCOVA
0.011
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
ANCOVA
0.047
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
ANCOVA
0.756
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Radial: Month 6
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00225
Title
Measurements
OG0001.007(0.993 to 1.021)
OG0011.000(0.986 to 1.015)
OG0020.998(0.984 to 1.013)
Radial: Month 12
ParticipantsOG00028
ParticipantsOG00122
ParticipantsOG00224
Title
Measurements
OG000
Radial: Month 18
ParticipantsOG00023
ParticipantsOG00117
ParticipantsOG00223
Title
Measurements
OG000
Radial: Month 24
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00216
Title
Measurements
OG000
Tibial: Month 6
ParticipantsOG00023
ParticipantsOG00120
ParticipantsOG00217
Title
Measurements
OG000
Tibial: Month 12
ParticipantsOG00024
ParticipantsOG00117
ParticipantsOG00215
Title
Measurements
OG000
Tibial: Month 18
ParticipantsOG00020
ParticipantsOG00113
ParticipantsOG00216
Title
Measurements
OG000
Tibial: Month 24
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00211
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Radial, Month 6
ANCOVA
0.329
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 6
ANCOVA
0.953
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 6
ANCOVA
0.795
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 12
ANCOVA
0.644
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 12
ANCOVA
0.485
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 12
ANCOVA
0.404
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 18
ANCOVA
0.827
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 18
ANCOVA
0.459
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 18
ANCOVA
0.022
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 24
ANCOVA
0.821
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 24
ANCOVA
0.911
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 24
ANCOVA
0.152
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 6
ANCOVA
0.668
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 6
ANCOVA
0.109
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 6
ANCOVA
0.358
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 12
ANCOVA
0.742
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 12
ANCOVA
0.567
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 12
ANCOVA
0.430
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 18
ANCOVA
0.634
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 18
ANCOVA
0.146
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 18
ANCOVA
0.521
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 24
ANCOVA
0.991
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 24
ANCOVA
0.069
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 24
ANCOVA
0.625
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
21
Title
Denominators
Categories
Radial: Month 6
ParticipantsOG00017
Title
Measurements
OG0000.994(0.972 to 1.017)
Radial: Month 12
ParticipantsOG00016
Title
Measurements
OG0001.011(0.986 to 1.036)
Tibial: Month 6
ParticipantsOG00015
Title
Measurements
OG0001.013(0.991 to 1.035)
Tibial: Month 12
ParticipantsOG00015
Title
Measurements
OG0001.035(0.975 to 1.099)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Radial, Month 6
ANCOVA
0.615
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 12
ANCOVA
0.376
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 6
ANCOVA
0.259
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 12
ANCOVA
0.253
Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Radial: Month 6
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG00031.22(-1.80 to 64.23)
OG00139.95(6.63 to 73.27)
OG002-3.28(-36.57 to 30.00)
Radial: Month 12
ParticipantsOG00028
ParticipantsOG00122
ParticipantsOG00225
Title
Measurements
OG000
Radial: Month 18
ParticipantsOG00023
ParticipantsOG00117
ParticipantsOG00224
Title
Measurements
OG000
Radial: Month 24
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00217
Title
Measurements
OG000
Tibial: Month 6
ParticipantsOG00023
ParticipantsOG00120
ParticipantsOG00217
Title
Measurements
OG000
Tibial: Month 12
ParticipantsOG00024
ParticipantsOG00117
ParticipantsOG00215
Title
Measurements
OG000
Tibial: Month 18
ParticipantsOG00020
ParticipantsOG00113
ParticipantsOG00216
Title
Measurements
OG000
Tibial: Month 24
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00211
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Radial, Month 6
ANCOVA
0.064
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 6
ANCOVA
0.019
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 6
ANCOVA
0.845
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 12
ANCOVA
0.006
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 12
ANCOVA
0.190
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 12
ANCOVA
0.704
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 18
ANCOVA
0.002
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 18
ANCOVA
0.021
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 18
ANCOVA
0.504
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 24
ANCOVA
0.462
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 24
ANCOVA
0.134
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 24
ANCOVA
0.086
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 6
ANCOVA
0.199
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 8
ANCOVA
0.219
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 6
ANCOVA
0.112
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 12
ANCOVA
0.086
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 12
ANCOVA
0.245
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 12
ANCOVA
0.232
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 18
ANCOVA
0.237
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 18
ANCOVA
0.088
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 18
ANCOVA
0.302
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 24
ANCOVA
0.626
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 8
ANCOVA
0.517
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 24
ANCOVA
0.262
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
21
Title
Denominators
Categories
Radial: Month 6
ParticipantsOG00016
Title
Measurements
OG000110.16(61.30 to 159.01)
Radial: Month 12
ParticipantsOG00015
Title
Measurements
OG00088.32(28.55 to 148.09)
Tibial: Month 6
ParticipantsOG00015
Title
Measurements
OG00069.78(-8.61 to 148.18)
Tibial: Month 12
ParticipantsOG00015
Title
Measurements
OG000112.92(10.76 to 215.07)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Radial, Month 6
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 12
ANCOVA
0.004
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 6
ANCOVA
0.080
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 12
ANCOVA
0.031
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Radial: Month 6
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG000795.67(-34.71 to 1626.04)
OG0011048.61(209.47 to 1887.75)
OG002109.65(-728.52 to 947.82)
Radial: Month 12
ParticipantsOG00028
ParticipantsOG00122
ParticipantsOG00225
Title
Measurements
OG000
Radial: Month 18
ParticipantsOG00023
ParticipantsOG00117
ParticipantsOG00224
Title
Measurements
OG000
Radial: Month 24
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00217
Title
Measurements
OG000
Tibial: Month 6
ParticipantsOG00023
ParticipantsOG00120
ParticipantsOG00217
Title
Measurements
OG000
Tibial: Month 12
ParticipantsOG00024
ParticipantsOG00117
ParticipantsOG00215
Title
Measurements
OG000
Tibial: Month 18
ParticipantsOG00020
ParticipantsOG00113
ParticipantsOG00216
Title
Measurements
OG000
Tibial: Month 24
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00211
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Radial, Month 6
ANCOVA
0.060
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 6
ANCOVA
0.015
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 6
ANCOVA
0.795
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 12
ANCOVA
0.011
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 12
ANCOVA
0.047
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 12
ANCOVA
0.756
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 18
ANCOVA
0.006
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 18
ANCOVA
0.137
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 18
ANCOVA
0.639
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 24
ANCOVA
0.325
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 24
ANCOVA
0.108
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 24
ANCOVA
0.078
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 6
ANCOVA
0.106
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 6
ANCOVA
0.236
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 6
ANCOVA
0.164
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 12
ANCOVA
0.031
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 12
ANCOVA
0.224
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 12
ANCOVA
0.291
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 18
ANCOVA
0.324
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 18
ANCOVA
0.188
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 18
ANCOVA
0.503
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 24
ANCOVA
0.385
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 24
ANCOVA
0.727
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 24
ANCOVA
0.338
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
21
Title
Denominators
Categories
Radial: Month 6
ParticipantsOG00016
Title
Measurements
OG0005056.51(3404.58 to 6708.45)
Radial: Month 12
ParticipantsOG00015
Title
Measurements
OG0004992.82(3056.80 to 6928.84)
Tibial: Month 6
ParticipantsOG00015
Title
Measurements
OG0004225.92(1840.16 to 6611.68)
Tibial: Month 12
ParticipantsOG00015
Title
Measurements
OG0005827.81(2601.54 to 9054.08)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Radial, Month 6
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 12
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 6
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 12
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Peripheral
Title
Measurements
OG0006.5
OG00117.2
OG00213.3
Vertebral
Title
Measurements
OG0000
OG0010
OG0020
Long-Bone
Title
Measurements
OG0003.2
OG00113.8
OG0023.3
Any
Title
Measurements
OG00016.1
OG00134.5
OG00223.3
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Lumbar
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG0000.273(0.142 to 0.405)
OG0010.338(0.213 to 0.464)
OG0020.110(-0.014 to 0.233)
Total Body
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00227
Title
Measurements
OG000
Femoral Neck
ParticipantsOG00021
ParticipantsOG00119
ParticipantsOG00224
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Lumbar
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Lumbar
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Lumbar
ANCOVA
0.080
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Total body
ANCOVA
0.238
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Total body
ANCOVA
0.238
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Total body
ANCOVA
0.035
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Femoral neck
ANCOVA
0.687
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Femoral neck
ANCOVA
0.107
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Femoral neck
ANCOVA
0.128
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Lumbar
ParticipantsOG00024
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG0004.06(2.12 to 6.00)
OG0014.70(2.86 to 6.55)
OG0021.58(-0.24 to 3.40)
Total Body
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00227
Title
Measurements
OG000
Femoral Neck
ParticipantsOG00021
ParticipantsOG00119
ParticipantsOG00224
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Lumbar
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Lumbar
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Lumbar
ANCOVA
0.088
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Total body
ANCOVA
0.184
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Total body
ANCOVA
0.144
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Total body
ANCOVA
0.028
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Femoral neck
ANCOVA
0.694
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Femoral neck
ANCOVA
0.143
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Femoral neck
ANCOVA
0.111
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Lumbar
ParticipantsOG00024
ParticipantsOG00122
ParticipantsOG00225
Title
Measurements
OG0000.587(0.427 to 0.746)
OG0010.486(0.324 to 0.648)
OG0020.174(0.022 to 0.327)
Total Body
ParticipantsOG00023
ParticipantsOG00122
ParticipantsOG00226
Title
Measurements
OG000
Femoral Neck
ParticipantsOG00021
ParticipantsOG00118
ParticipantsOG00222
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Lumbar
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Lumbar
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Lumbar
ANCOVA
0.026
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Total body
ANCOVA
0.007
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Total body
ANCOVA
0.004
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Total body
ANCOVA
0.085
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Femoral neck
ANCOVA
0.040
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Femoral neck
ANCOVA
0.061
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Femoral neck
ANCOVA
0.189
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Lumbar
ParticipantsOG00024
ParticipantsOG00122
ParticipantsOG00225
Title
Measurements
OG0008.55(6.13 to 10.97)
OG0016.79(4.34 to 9.25)
OG0022.50(0.19 to 4.81)
Total Body
ParticipantsOG00023
ParticipantsOG00122
ParticipantsOG00226
Title
Measurements
OG000
Femoral Neck
ParticipantsOG00021
ParticipantsOG00118
ParticipantsOG00222
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Lumbar
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Lumbar
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Lumbar
ANCOVA
0.035
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Total body
ANCOVA
0.003
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Total body
ANCOVA
0.003
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Total body
ANCOVA
0.088
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Femoral neck
ANCOVA
0.016
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Femoral neck
ANCOVA
0.068
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Femoral neck
ANCOVA
0.160
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Radial, Month 6
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG0001.011(0.999 to 1.022)
OG0010.995(0.984 to 1.007)
OG0021.000(0.989 to 1.012)
Radial, Month 12
ParticipantsOG00028
ParticipantsOG00122
ParticipantsOG00225
Title
Measurements
OG000
Radial, Month 18
ParticipantsOG00023
ParticipantsOG00117
ParticipantsOG00224
Title
Measurements
OG000
Radial, Month 24
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00217
Title
Measurements
OG000
Tibial, Month 6
ParticipantsOG00023
ParticipantsOG00120
ParticipantsOG00217
Title
Measurements
OG000
Tibial, Month 12
ParticipantsOG00024
ParticipantsOG00117
ParticipantsOG00215
Title
Measurements
OG000
Tibial, Month 18
ParticipantsOG00020
ParticipantsOG00113
ParticipantsOG00216
Title
Measurements
OG000
Tibial, Month 24
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00211
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Radial, Month 6
ANCOVA
0.065
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 6
ANCOVA
0.405
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 6
ANCOVA
0.966
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 12
ANCOVA
0.003
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 12
ANCOVA
0.229
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 12
ANCOVA
0.807
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 18
ANCOVA
0.042
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 18
ANCOVA
0.283
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 18
ANCOVA
0.536
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 24
ANCOVA
0.765
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 24
ANCOVA
0.247
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 24
ANCOVA
0.050
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 6
ANCOVA
0.037
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 6
ANCOVA
0.174
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 6
ANCOVA
0.558
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 12
ANCOVA
0.020
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 12
ANCOVA
0.346
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 12
ANCOVA
0.387
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 18
ANCOVA
0.093
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 18
ANCOVA
0.156
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 18
ANCOVA
0.324
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 24
ANCOVA
0.920
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 24
ANCOVA
0.040
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 24
ANCOVA
0.643
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Radial, Month 6
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG0001.004(0.997 to 1.010)
OG0011.002(0.996 to 1.009)
OG0020.998(0.992 to 1.005)
Radial, Month 12
ParticipantsOG00028
ParticipantsOG00122
ParticipantsOG00225
Title
Measurements
OG000
Radial, Month 18
ParticipantsOG00023
ParticipantsOG00117
ParticipantsOG00224
Title
Measurements
OG000
Radial, Month 24
ParticipantsOG00021
ParticipantsOG00116
ParticipantsOG00217
Title
Measurements
OG000
Tibial, Month 6
ParticipantsOG00023
ParticipantsOG00120
ParticipantsOG00217
Title
Measurements
OG000
Tibial, Month 12
ParticipantsOG00024
ParticipantsOG00117
ParticipantsOG00215
Title
Measurements
OG000
Tibial, Month 18
ParticipantsOG00020
ParticipantsOG00113
ParticipantsOG00216
Title
Measurements
OG000
Tibial, Month 24
ParticipantsOG00019
ParticipantsOG00112
ParticipantsOG00211
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Radial, Month 6
ANCOVA
0.285
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 6
ANCOVA
0.544
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 6
ANCOVA
0.615
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 12
ANCOVA
0.179
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 12
ANCOVA
0.513
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 12
ANCOVA
0.849
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 18
ANCOVA
0.037
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 18
ANCOVA
0.880
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 18
ANCOVA
0.153
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Radial, Month 24
ANCOVA
0.073
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Radial, Month 24
ANCOVA
0.007
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Radial, Month 24
ANCOVA
0.791
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 6
ANCOVA
0.010
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 6
ANCOVA
0.553
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 6
ANCOVA
0.652
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 12
ANCOVA
< 0.001
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 12
ANCOVA
0.482
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 12
ANCOVA
0.685
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 18
ANCOVA
0.002
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 18
ANCOVA
0.672
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 18
ANCOVA
0.377
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Tibial, Month 24
ANCOVA
0.015
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Tibial, Month 24
ANCOVA
0.086
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Tibial, Month 24
ANCOVA
0.712
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 6: Body Height
Title
Measurements
OG0000
OG0010
OG0020
Month 6: Weight
Title
Measurements
OG0000
OG0010
OG0020
Month 6: BMI
Title
Measurements
OG0000
OG0010
OG0020
Month 12: Body Height
Title
Measurements
OG0000
OG0010
OG0020
Month 12: Weight
Title
Measurements
OG0000
OG0010
OG0020
Month 12: BMI
Title
Measurements
OG0000
OG0010
OG0020
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 6: Lean
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00227
Title
Measurements
OG000519.152(13.020 to 1025.284)
OG001-410.664(-903.724 to 82.395)
OG002168.206(-306.981 to 643.393)
Month 12: Lean
ParticipantsOG00023
ParticipantsOG00122
ParticipantsOG00226
Title
Measurements
OG000
Month 6: Fat
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00227
Title
Measurements
OG000
Month 12: Fat
ParticipantsOG00023
ParticipantsOG00122
ParticipantsOG00226
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Lean, Month 6
ANCOVA
0.045
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Lean, Month 6
ANCOVA
0.101
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Lean, Month 6
ANCOVA
0.482
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Lean, Month 12
ANCOVA
0.011
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Lean, Month 12
ANCOVA
0.508
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Lean, Month 12
ANCOVA
0.563
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Fat, Month 6
ANCOVA
0.917
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Fat, Month 6
ANCOVA
0.789
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Fat, Month 6
ANCOVA
0.262
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Fat, Month 12
ANCOVA
0.426
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Fat, Month 12
ANCOVA
0.871
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Fat, Month 12
ANCOVA
0.113
Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 1
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00229
Title
Measurements
OG00024.349(18.604 to 30.095)
OG00114.288(8.221 to 20.354)
OG0020.060(-5.827 to 5.948)
Month 3
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00225
Title
Measurements
OG000
Month 6
ParticipantsOG00027
ParticipantsOG00128
ParticipantsOG00227
Title
Measurements
OG000
Month 9
ParticipantsOG00027
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG000
Month 12
ParticipantsOG00025
ParticipantsOG00120
ParticipantsOG00220
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Month 1
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 1
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 1
ANCOVA
0.984
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 3
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 3
ANCOVA
0.050
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 3
ANCOVA
0.857
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 6
ANCOVA
0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 6
ANCOVA
0.079
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 6
ANCOVA
0.912
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 9
ANCOVA
0.054
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 9
ANCOVA
0.950
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 9
ANCOVA
0.555
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 12
ANCOVA
0.221
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 12
ANCOVA
0.393
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 12
ANCOVA
0.385
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 1
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00229
Title
Measurements
OG000-0.077(-0.100 to -0.054)
OG001-0.047(-0.071 to -0.022)
OG002-0.041(-0.064 to -0.017)
Month 3
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00225
Title
Measurements
OG000
Month 6
ParticipantsOG00027
ParticipantsOG00128
ParticipantsOG00227
Title
Measurements
OG000
Month 9
ParticipantsOG00027
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG000
Month 12
ParticipantsOG00025
ParticipantsOG00120
ParticipantsOG00220
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Month 1
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 1
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 1
ANCOVA
< 0.001
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 3
ANCOVA
0.003
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 3
ANCOVA
0.050
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 3
ANCOVA
0.006
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 6
ANCOVA
0.519
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 6
ANCOVA
0.226
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 6
ANCOVA
0.190
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 9
ANCOVA
0.388
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 9
ANCOVA
0.109
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 9
ANCOVA
0.204
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 12
ANCOVA
0.119
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 12
ANCOVA
0.925
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 12
ANCOVA
0.204
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 6
ParticipantsOG00027
ParticipantsOG00129
ParticipantsOG00227
Title
Measurements
OG0000.672(-1.788 to 3.132)
OG001-0.463(-2.821 to 1.895)
OG0021.342(-1.129 to 3.814)
Month 12
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00226
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Month 6
ANCOVA
0.588
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 6
ANCOVA
0.697
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 6
ANCOVA
0.283
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 12
ANCOVA
0.354
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 12
ANCOVA
0.430
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 12
ANCOVA
0.091
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 6
ParticipantsOG00027
ParticipantsOG00129
ParticipantsOG00227
Title
Measurements
OG0000.966(-2.064 to 3.996)
OG001-0.492(-3.411 to 2.427)
OG002-1.133(-4.202 to 1.936)
Month 12
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00226
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Month 6
ANCOVA
0.527
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 6
ANCOVA
0.738
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 6
ANCOVA
0.465
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 12
ANCOVA
0.068
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 12
ANCOVA
0.328
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 12
ANCOVA
0.277
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 6
ParticipantsOG00027
ParticipantsOG00128
ParticipantsOG00226
Title
Measurements
OG0000.0627(-0.0105 to 0.1359)
OG0010.0362(-0.0343 to 0.1067)
OG002-0.0383(-0.1121 to 0.0354)
Month 12
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Month 6
ANCOVA
0.092
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 6
ANCOVA
0.310
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 6
ANCOVA
0.304
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 12
ANCOVA
0.155
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 12
ANCOVA
0.392
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 12
ANCOVA
0.464
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 6
ParticipantsOG00027
ParticipantsOG00125
ParticipantsOG00226
Title
Measurements
OG000-3.584(-8.491 to 1.324)
OG001-1.848(-6.899 to 3.203)
OG002-0.649(-5.751 to 4.452)
Month 12
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00225
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Month 6
ANCOVA
0.150
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 6
ANCOVA
0.468
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 6
ANCOVA
0.800
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 12
ANCOVA
0.563
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 12
ANCOVA
0.839
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 12
ANCOVA
0.186
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 6
ParticipantsOG00027
ParticipantsOG00126
ParticipantsOG00226
Title
Measurements
OG000-3.990(-11.267 to 3.287)
OG001-3.906(-11.239 to 3.426)
OG002-6.003(-13.495 to 1.489)
Month 12
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00225
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Month 6
ANCOVA
0.278
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 6
ANCOVA
0.292
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 6
ANCOVA
0.115
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 12
ANCOVA
0.356
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 12
ANCOVA
0.205
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 12
ANCOVA
0.078
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Units
Counts
Participants
OG00031
OG00129
OG00230
Title
Denominators
Categories
Month 6
ParticipantsOG00027
ParticipantsOG00126
ParticipantsOG00226
Title
Measurements
OG000-5.980(-11.597 to -0.363)
OG001-2.722(-8.397 to 2.953)
OG0021.907(-3.906 to 7.719)
Month 12
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00225
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Month 6
ANCOVA
0.037
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 6
ANCOVA
0.342
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 6
ANCOVA
0.515
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG000
Month 12
ANCOVA
0.786
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG001
Month 12
ANCOVA
0.212
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
OG002
Month 12
ANCOVA
0.655
Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.
Superiority
Comparison is between the Visit and Baseline
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG004
Placebo
Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Due to a protocol amendment, placebo was actually received for an average of 5 months.
Units
Counts
Participants
OG00031
OG00129
OG00230
OG00321
OG00420
Title
Denominators
Categories
Binding Antibodies
Title
Measurements
OG00016.1
OG00117.2
OG00216.7
OG0039.5
OG00415.0
Neutralizing Antibodies
Title
Measurements
OG00016.1
OG00117.2
OG00216.7
OG003
Both Binding and Neutralizing Antibodies
Title
Measurements
OG00016.1
OG00117.2
OG00216.7
OG003
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG002
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG003
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
OG004
Placebo
Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules. Due to a protocol amendment, placebo was actually received for an average of 5 months.
Units
Counts
Participants
OG00031
OG00129
OG00230
OG00321
OG00420
Title
Denominators
Categories
All AEs
Title
Measurements
OG000100.0
OG00196.6
OG00290.0
OG003100.0
OG00490.0
TEAEs
Title
Measurements
OG000100.0
OG00196.6
OG00290.0
OG003
Treatment-Related TEAEs
Title
Measurements
OG00071.0
OG00141.4
OG00236.7
OG003
Serious TEAEs
Title
Measurements
OG00012.9
OG00124.1
OG00223.3
OG003
Treatment-Related Serious TEAEs
Title
Measurements
OG0006.5
OG0010
OG0020
OG003
TEAEs Leading to Death
Title
Measurements
OG0000
OG0010
OG0020
OG003
TEAEs Leading to Permanent Study Treatment Discontinuation