A Dose-Ranging Study of MK-5442 in Postmenopausal Women W... | NCT00960934 | Trialant
NCT00960934
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Feb 18, 2015Estimated
Enrollment
383Actual
Phase
Phase 2
Conditions
Osteoporosis
Interventions
MK-5442
Placebo
Vitamin D3
Calcium carbonate
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00960934
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
5442-001
Secondary IDs
ID
Type
Description
Link
2009-012926-35
EudraCT Number
Brief Title
A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)
Official Title
A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women With Osteoporosis
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2015
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2009
Primary Completion Date
Dec 2010Actual
Completion Date
Dec 2010Actual
First Submitted Date
Aug 17, 2009
First Submission Date that Met QC Criteria
Aug 17, 2009
First Posted Date
Aug 18, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 14, 2012
Results First Submitted that Met QC Criteria
Oct 2, 2012
Results First Posted Date
Oct 10, 2012Estimated
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
Feb 1, 2015
Last Update Posted Date
Feb 18, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 was to identify an appropriate dose of
MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.
Detailed Description
Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.
Conditions Module
Conditions
Osteoporosis
Keywords
Osteoporosis
Postmenopausal
MK-5442
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
383Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-5442 2.5 mg
Experimental
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
Drug: MK-5442
Drug: Placebo
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium carbonate
MK-5442 5 mg
Experimental
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
Drug: MK-5442
Drug: Placebo
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium carbonate
MK-5442 7.5 mg
Experimental
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
Drug: MK-5442
Drug: Placebo
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium carbonate
MK-5442 10 mg
Experimental
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
Drug: MK-5442
Drug: Placebo
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium carbonate
MK-5442 15 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-5442
Drug
MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.
MK-5442 10 mg
MK-5442 15 mg
MK-5442 2.5 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)
Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Baseline (BL) and Month 6
Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change
Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).
Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
Baseline through Month 6
Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change
Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).
≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
Baseline through Month 6
Percentage of Participants With Kidney Stones
Evidence of kidney stone(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
Baseline through Month 6
Percentage of Participants With Bone Neoplasms
Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
Baseline through Month 6
Secondary Outcomes
Measure
Description
Time Frame
LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD
DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Postmenopausal for at least 5 years
No history of fragility fracture, unless participant is not willing to take marketed osteoporosis therapy or is not a candidate for marketed osteoporosis therapy
Agrees not to use medications for osteoporosis except medications associated with the study
Areal bone mineral density (BMD) T-score <-2.5 at one or more of the following 4 BMD sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal BMD T-scores of < -3.5
Exclusion Criteria:
Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie, weight >250 lbs)
Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3 months in the past 2 years, or lifetime use of more than 6 months
Use of intravenous bisphosphonates, strontium, or growth hormone at any time
Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within 6 months prior to Visit 1
Use of pioglitazone or rosiglitazone at study screening
Use of estrogen ± progestin, in any form other than vaginal or topical application, for 6 months prior to Study Visit 1
Prior total thyroidectomy
Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome (AIDS)-related illness
History of malignant cancer within 5 years of study screening, except for certain skin or cervical cancers
History of Paget's disease and/or kidney stones
An active user of any illicit drug
History of or active alcohol abuse
Participated in an investigational drug study within the past 30 days
Halse J, Greenspan S, Cosman F, Ellis G, Santora A, Leung A, Heyden N, Samanta S, Doleckyj S, Rosenberg E, Denker AE. A phase 2, randomized, placebo-controlled, dose-ranging study of the calcium-sensing receptor antagonist MK-5442 in the treatment of postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2014 Nov;99(11):E2207-15. doi: 10.1210/jc.2013-4009. Epub 2014 Aug 28.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
383 participants were randomized on study and 380 participants were treated on study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
FG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
FG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
FG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
FG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
FG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00064 subjects
FG00163 subjects
FG00264 subjects
FG00364 subjects
FG00464 subjects
FG00564 subjects
Number Treated
FG00064 subjects
FG00162 subjects1 participant was randomized but not treated
FG00264 subjects
FG00364 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00064 subjects
FG00163 subjects
FG00264 subjects
FG00364 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
BG001
MK-5442 5 mg
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)
Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline (BL) and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
Adverse Events Module
Frequency Threshold
0.05
Time Frame
From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011
Description
All Participants as Treated (APaT) Population. Three participants were randomized but not treated, and thus are not included in the adverse event table calculations (one participant was randomized to 5 mg MK-5442; one participant was randomized to 15 mg MK-5442 and one participant was randomized to Placebo.
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
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris aggravated
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp and Dohme Corp.
1-800-672-6372
ClinicalTrialDisclosure@merck.com
Jul 10, 2026
Removed Countries
Denmark
Norway
Russia
South Africa
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D010024
Osteoporosis
Ancestor Terms
ID
Term
D001851
Bone Diseases, Metabolic
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D008659
Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C568849
JTT 305
D002762
Cholecalciferol
D002119
Calcium Carbonate
Ancestor Terms
ID
Term
D002782
Cholestenes
D002776
Cholestanes
D013256
Steroids
D000072473
Fused-Ring Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Experimental
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
Drug: MK-5442
Drug: Placebo
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium carbonate
Placebo
Placebo Comparator
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Drug: Placebo
Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium carbonate
MK-5442 5 mg
MK-5442 7.5 mg
Placebo
Drug
Dose-matched oral placebo to MK-5442
MK-5442 10 mg
MK-5442 15 mg
MK-5442 2.5 mg
MK-5442 5 mg
MK-5442 7.5 mg
Placebo
Vitamin D3
Dietary Supplement
Vitamin D3, two 400 IU tablets daily throughout the study.
MK-5442 10 mg
MK-5442 15 mg
MK-5442 2.5 mg
MK-5442 5 mg
MK-5442 7.5 mg
Placebo
Calcium carbonate
Dietary Supplement
Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.
MK-5442 10 mg
MK-5442 15 mg
MK-5442 2.5 mg
MK-5442 5 mg
MK-5442 7.5 mg
Placebo
DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD
DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD
DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD
DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip
Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine
Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)
The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)
C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.
Baseline to Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).
Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)
Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.
Baseline to Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin
Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).
Baseline and Month 6
FG00463 subjects1 participant was randomized but not treated
FG00563 subjects1 participant was randomized but not treated
0 subjects
FG0050 subjects
64 subjects
FG00564 subjects
2 subjects
FG0044 subjects
FG0053 subjects
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Other
FG0002 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
FG0042 subjects
FG0052 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Progressive Disease
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
Protocol Violation
FG0003 subjects
FG0014 subjects
FG0020 subjects
FG0033 subjects
FG0043 subjects
FG0052 subjects
Withdrawal by Subject
FG0005 subjects
FG0016 subjects
FG0024 subjects
FG0035 subjects
FG0045 subjects
FG0057 subjects
Study Terminated by Sponsor
FG00050 subjects
FG00146 subjects
FG00252 subjects
FG00350 subjects
FG00449 subjects
FG00549 subjects
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
BG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
BG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
BG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
BG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
BG006
Total
Total of all reporting groups
64
BG00163
BG00264
BG00364
BG00464
BG00564
BG006383
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00066.7± 6.3
BG00167.3± 6.5
BG00267.4± 6.0
BG00367.8± 6.4
BG00466.5± 5.4
BG00567.6± 6.7
BG00667.2± 6.2
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00064
BG00163
BG00264
BG00364
BG00464
BG00564
BG006383
Male
BG0000
BG0010
BG0020
BG0030
BG004
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00058
OG00154
OG00256
OG00355
OG00456
OG00556
Title
Denominators
Categories
Title
Measurements
OG0000.74(-0.21 to 1.68)
OG0011.50(0.53 to 2.48)
OG0020.92(-0.02 to 1.87)
OG0031.69(0.73 to 2.64)
OG0041.13(0.18 to 2.08)
OG0050.57(-0.40 to 1.55)
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
OG004
OG005
Longitudinal Data Analysis Model
0.749
The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.56
2-Sided
95
-1.04
2.16
No
Superiority or Other
OG003
OG005
Longitudinal Data Analysis Model
0.333
The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
1.12
2-Sided
95
-0.60
2.83
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.823
The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.35
2-Sided
95
-1.14
1.84
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.457
The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.93
2-Sided
95
-0.75
2.61
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.823
The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.16
2-Sided
95
-1.17
1.50
No
Superiority or Other
Primary
Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change
Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).
Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.
Posted
Number
Percentage of participants
Baseline through Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00064
OG00162
OG00264
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.8
OG00132.3
OG00232.8
OG003
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
OG004
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
<0.001
Mean Difference (Final Values)
69.8
95
56.5
80.0
No
Superiority or Other
Primary
Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change
Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).
≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.
Posted
Number
Percentage of participants
Baseline through Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00064
OG00162
OG00264
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0019.7(2.96 to 5.35)
OG00218.8(2.75 to 5.09)
OG003
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
OG004
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
<0.001
Mean Difference (Final Values)
47.6
2-Sided
95
34.9
60.0
No
Superiority or Other
Primary
Percentage of Participants With Kidney Stones
Evidence of kidney stone(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.
Posted
Number
Percentage of participants
Baseline through Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00064
OG00162
OG00264
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.6
OG0011.6
OG0020.0
OG003
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
OG004
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
>0.999
Mean Difference (Final Values)
0.0
2-Sided
95
-5.8
5.8
No
Superiority or Other
Primary
Percentage of Participants With Bone Neoplasms
Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.
Posted
Number
Percentage of participants
Baseline through Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00064
OG00162
OG00264
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Secondary
LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD
DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00058
OG00154
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.20(-0.95 to 0.55)
OG001-0.32(-1.10 to 0.46)
OG0020.32(-0.43 to 1.07)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
0.959
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.24
2-Sided
95
-1.03
1.51
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD
DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00058
OG00154
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.23(0.21 to 2.25)
OG001-0.52(-1.58 to 0.54)
OG0020.12(-0.89 to 1.14)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
0.849
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.58
2-Sided
95
-1.22
2.37
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD
DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00058
OG00154
OG00256
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.41(-0.78 to 1.60)
OG0010.95(-0.29 to 2.19)
OG0020.54(-0.65 to 1.74)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
0.933
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.60
2-Sided
95
-1.56
2.77
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD
DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00051
OG00151
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.43(-0.11 to 0.97)
OG0010.28(-0.28 to 0.84)
OG0020.80(0.27 to 1.33)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
0.976
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.17
2-Sided
95
-1.12
0.77
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD
DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00051
OG00151
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.47(-1.42 to 0.48)
OG001-0.32(-1.30 to 0.65)
OG0020.44(-0.47 to 1.36)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
0.961
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.35
2-Sided
95
-2.00
1.31
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip
Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).
Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00042
OG00143
OG00246
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.41(-1.44 to 0.62)
OG001-0.34(-1.43 to 0.75)
OG002-0.89(-1.90 to 0.13)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
0.901
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.43
2-Sided
95
-2.03
1.17
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine
Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).
Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00043
OG00143
OG00244
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.94(0.13 to 3.75)
OG0010.94(-0.97 to 2.85)
OG0021.83(0.02 to 3.64)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
0.979
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.37
2-Sided
95
-2.73
1.99
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)
The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).
Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00050
OG00151
OG00253
OG003
Title
Denominators
Categories
Title
Measurements
OG000-12.18(-21.23 to -2.10)
OG001-9.46(-18.87 to 1.03)
OG002-20.73(-28.79 to -11.76)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
0.020
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
19.77
2-Sided
95
2.26
37.46
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)
C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.
Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline to Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00049
OG00151
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG000-15.39(-23.80 to -6.05)
OG001-5.87(-15.32 to 4.63)
OG002-4.93(-14.23 to 5.39)
OG003
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
OG004
OG005
Longitudinal Data Analysis
<0.001
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
34.26
2-Sided
95
15.27
53.56
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).
Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00049
OG00151
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.60(-6.87 to 6.10)
OG0010.26(-6.17 to 7.13)
OG0024.39(-2.13 to 11.35)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
<0.001
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
19.19
2-Sided
95
7.42
31.02
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)
Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.
The 'Per Protocol' population was used for this analysis. The Per-Protocol population was defined as a subset population that excluded participants based on critical protocol violations.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline to Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00049
OG00151
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG000-9.97(-18.46 to -0.59)
OG001-9.76(-18.36 to -0.26)
OG0022.33(-7.16 to 12.78)
OG003
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
OG004
OG005
Longitudinal Data Analysis
<.001
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
56.77
2-Sided
95
37.62
76.35
No
Superiority or Other
OG003
OG005
Secondary
LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin
Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).
Per Protocol population; defined as the subset of the APaT population that excluded participants based on critical protocol violations.
Posted
Least Squares Mean
95% Confidence Interval
percent change
Baseline and Month 6
ID
Title
Description
OG000
MK-5442 2.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
OG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
OG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
OG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
OG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
OG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
Units
Counts
Participants
OG00049
OG00151
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG000-11.61(-18.19 to -4.50)
OG001-2.75(-10.10 to 5.19)
OG0029.18(1.15 to 17.86)
OG003
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
OG004
OG005
Longitudinal Data Analysis Model
<0.001
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
53.05
2-Sided
95
37.83
68.53
No
Superiority or Other
OG003
OG005
3
64
18
64
EG001
MK-5442 5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
0
62
24
62
EG002
MK-5442 7.5 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
4
64
15
64
EG003
MK-5442 10 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
5
64
28
64
EG004
MK-5442 15 mg
Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
4
63
18
63
EG005
Placebo
Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
3
63
26
63
EG0001 events1 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Atrial flutter
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Breast cancer stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Breast cyst
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Burn
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0041 events1 affected63 at risk
EG0050 events0 affected63 at risk
COPD exacerbation
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Cellulitis of leg
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0001 events1 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Cholelithiasis
Hepatobiliary disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0041 events1 affected63 at risk
EG0050 events0 affected63 at risk
Coronary stent stenosis
Injury, poisoning and procedural complications
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0051 events1 affected63 at risk
External haemorrhoids
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Fracture malunion
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0051 events1 affected63 at risk
Gallbladder carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0041 events1 affected63 at risk
EG0050 events0 affected63 at risk
Ischaemic heart disease
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Ovarian cyst
Reproductive system and breast disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0041 events1 affected63 at risk
EG0050 events0 affected63 at risk
Paroxysmal atrial fibrillation
Cardiac disorders
MedDRA 14.0
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Peptic ulcer
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0041 events1 affected63 at risk
EG0050 events0 affected63 at risk
Postural hypotension
Vascular disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Pyelonephritis acute
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Sciatica
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected63 at risk
EG0051 events1 affected63 at risk
Stroke
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected63 at risk
EG0050 events0 affected63 at risk
EG0002 events2 affected64 at risk
EG0014 events4 affected62 at risk
EG0024 events4 affected64 at risk
EG0037 events7 affected64 at risk
EG0045 events5 affected63 at risk
EG0056 events4 affected63 at risk
Nausea
Gastrointestinal disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected64 at risk
EG0010 events0 affected62 at risk
EG0023 events2 affected64 at risk
EG0032 events2 affected64 at risk
EG0042 events2 affected63 at risk
EG0055 events5 affected63 at risk
Tiredness
General disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected64 at risk
EG0040 events0 affected63 at risk
EG0055 events4 affected63 at risk
Chest Infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected64 at risk
EG0012 events1 affected62 at risk
EG0021 events1 affected64 at risk
EG0034 events4 affected64 at risk
EG0042 events2 affected63 at risk
EG0051 events1 affected63 at risk
Common Cold
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0004 events4 affected64 at risk
EG0013 events3 affected62 at risk
EG0023 events3 affected64 at risk
EG0035 events5 affected64 at risk
EG0041 events1 affected63 at risk
EG0055 events3 affected63 at risk
Upper Respiratory Tract Infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0003 events3 affected64 at risk
EG0012 events2 affected62 at risk
EG0022 events2 affected64 at risk
EG0032 events2 affected64 at risk
EG0043 events3 affected63 at risk
EG0057 events6 affected63 at risk
Urinary Tract Infection
Infections and infestations
MedDRA (14.0)
Systematic Assessment
EG0008 events5 affected64 at risk
EG0016 events5 affected62 at risk
EG0023 events2 affected64 at risk
EG00312 events10 affected64 at risk
EG0045 events3 affected63 at risk
EG0056 events6 affected63 at risk
Pain in Hip
Musculoskeletal and connective tissue disorders
MedDRA (14.0)
Systematic Assessment
EG0000 events0 affected64 at risk
EG0015 events4 affected62 at risk
EG0021 events1 affected64 at risk
EG0030 events0 affected64 at risk
EG0043 events3 affected63 at risk
EG0051 events1 affected63 at risk
Headache
Nervous system disorders
MedDRA (14.0)
Systematic Assessment
EG0005 events5 affected64 at risk
EG0016 events6 affected62 at risk
EG0023 events2 affected64 at risk
EG0034 events4 affected64 at risk
EG0045 events5 affected63 at risk
EG0056 events5 affected63 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (14.0)
Systematic Assessment
EG0002 events2 affected64 at risk
EG0013 events3 affected62 at risk
EG0021 events1 affected64 at risk
EG0034 events4 affected64 at risk
EG0042 events2 affected63 at risk
EG0050 events0 affected63 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results of the study associated with their study site independently.
D009750
Nutritional and Metabolic Diseases
D011083
Polycyclic Compounds
D013261
Sterols
D014807
Vitamin D
D012632
Secosteroids
D008563
Membrane Lipids
D008055
Lipids
D017610
Calcium Compounds
D007287
Inorganic Chemicals
D002254
Carbonates
D002255
Carbonic Acid
D017554
Carbon Compounds, Inorganic
D008903
Minerals
0
BG0050
BG0060
64
OG00463
OG00563
56.3
OG00473.0
OG0053.2
OG003
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
<0.001
Mean Difference (Final Values)
53.1
2-Sided
95
39.6
65.2
No
Superiority or Other
OG002
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
<0.001
Mean Difference (Final Values)
29.6
2-Sided
95
17.6
42.4
No
Superiority or Other
OG001
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
<0.001
Mean Difference (Final Values)
29.1
2-Sided
95
17.0
42.0
No
Superiority or Other
OG000
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
0.254
Mean Difference (Final Values)
4.6
2-Sided
95
-4.1
14.4
No
Superiority or Other
64
OG00463
OG00563
37.5
(4.28 to 6.69)
OG00449.2(5.10 to 7.50)
OG0051.6(-1.04 to 1.22)
OG003
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
<0.001
Mean Difference (Final Values)
35.9
2-Sided
95
24.1
48.5
No
Superiority or Other
OG002
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
0.001
Mean Difference (Final Values)
17.2
2-Sided
95
7.7
28.7
No
Superiority or Other
OG001
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
0.050
Mean Difference (Final Values)
8.1
2-Sided
95
-0.0
18.2
No
Superiority or Other
OG000
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
0.313
Mean Difference (Final Values)
-1.6
2-Sided
95
-8.5
4.2
No
Superiority or Other
64
OG00463
OG00563
0.0
OG0040.0
OG0050.0
OG003
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
>0.999
Mean Difference (Final Values)
0
2-Sided
95
-5.8
5.7
No
Superiority or Other
OG002
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
>0.999
Mean Difference (Final Values)
0.0
2-Sided
95
-5.8
5.7
No
Superiority or Other
OG001
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
0.313
Mean Difference (Final Values)
1.6
2-Sided
95
-4.2
8.6
No
Superiority or Other
OG000
OG005
The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.
Miettinen and Nurminen Method
0.321
Mean Difference (Final Values)
1.6
2-Sided
95
-4.3
8.4
No
Superiority or Other
64
OG00463
OG00563
0.0
OG0040.0
OG0050.0
55
OG00456
OG00556
0.07
(-0.69 to 0.82)
OG0040.33(-0.43 to 1.08)
OG0050.08(-0.69 to 0.86)
Longitudinal Data Analysis Model
0.971
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.02
2-Sided
95
-1.08
1.04
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.959
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.24
2-Sided
95
-0.95
1.42
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.915
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.41
2-Sided
95
-1.78
0.97
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.959
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.28
2-Sided
95
-1.60
1.04
No
Superiority or Other
55
OG00456
OG00556
-0.20
(-1.23 to 0.83)
OG0040.54(-0.48 to 1.56)
OG005-0.04(-1.09 to 1.01)
Longitudinal Data Analysis Model
0.964
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.16
2-Sided
95
-1.79
1.47
No
Superiority or Other
OG002
Longitudinal Data Analysis Model
0.964
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.16
2-Sided
95
-1.27
1.59
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.855
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.48
2-Sided
95
-2.23
1.27
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.287
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
1.27
2-Sided
95
-0.58
3.12
No
Superiority or Other
55
OG00456
OG00556
0.49
(-0.72 to 1.70)
OG0041.10(-0.11 to 2.30)
OG0050.49(-0.74 to 1.73)
Longitudinal Data Analysis Model
0.999
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.01
2-Sided
95
-1.69
1.68
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.999
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.05
2-Sided
95
-1.84
1.93
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.959
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.45
2-Sided
95
-1.67
2.57
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.999
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.08
2-Sided
95
-2.10
1.94
No
Superiority or Other
50
OG00453
OG00552
0.21
(-0.35 to 0.76)
OG0040.09(-0.44 to 0.63)
OG0050.27(-0.29 to 0.82)
Longitudinal Data Analysis Model
0.982
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.06
2-Sided
95
-0.93
0.80
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.489
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.53
2-Sided
95
-0.43
1.49
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.982
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.02
2-Sided
95
-0.75
0.78
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.976
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.16
2-Sided
95
-0.76
1.08
No
Superiority or Other
49
OG00453
OG00552
-0.49
(-1.46 to 0.48)
OG004-0.56(-1.50 to 0.37)
OG005-0.21(-1.18 to 0.76)
Longitudinal Data Analysis Model
0.961
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.28
2-Sided
95
-1.90
1.34
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.778
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.66
2-Sided
95
-1.01
2.33
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.961
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.11
2-Sided
95
-1.45
1.24
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.961
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.25
2-Sided
95
-1.77
1.26
No
Superiority or Other
39
OG00441
OG00550
-0.88
(-1.97 to 0.22)
OG004-0.80(-1.87 to 0.26)
OG005-0.37(-1.37 to 0.63)
Longitudinal Data Analysis Model
0.901
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.51
2-Sided
95
-2.18
1.17
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.901
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.52
2-Sided
95
-2.17
1.13
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.997
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.03
2-Sided
95
-1.29
1.35
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.997
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.04
2-Sided
95
-1.51
1.43
No
Superiority or Other
39
OG00440
OG00550
3.35
(1.43 to 5.27)
OG0041.06(-0.83 to 2.96)
OG0051.43(-0.33 to 3.19)
Longitudinal Data Analysis Model
0.363
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
1.92
2-Sided
95
-1.10
4.95
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.979
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.40
2-Sided
95
-2.18
2.98
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.979
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.49
2-Sided
95
-3.27
2.30
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.979
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
0.51
2-Sided
95
-2.34
3.37
No
Superiority or Other
51
OG00452
OG00553
-7.82
(-17.33 to 2.78)
OG0041.87(-8.53 to 13.45)
OG005-17.90(-26.15 to -8.73)
Longitudinal Data Analysis Model
0.357
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
10.08
2-Sided
95
-6.16
26.41
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.642
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-2.83
2-Sided
95
-14.81
9.14
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.434
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
8.44
2-Sided
95
-7.09
24.04
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.579
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
5.72
95
-8.62
20.10
No
Superiority or Other
52
OG00452
OG00552
5.68
(-4.77 to 17.27)
OG00419.37(7.60 to 32.43)
OG005-14.89(-23.24 to -5.64)
Longitudinal Data Analysis
0.014
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
20.57
2-Sided
95
3.28
38.02
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis
0.307
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
9.97
2-Sided
95
-5.69
25.70
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis
0.307
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
9.02
2-Sided
95
-5.85
23.95
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis
0.937
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
-0.50
2-Sided
95
-12.92
11.92
No
Superiority or Other
52
OG00452
OG00552
17.33
(9.93 to 25.22)
OG00413.13(6.02 to 20.72)
OG005-6.05(-11.92 to 0.20)
Longitudinal Data Analysis Model
<0.001
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
23.38
2-Sided
95
11.02
35.82
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
0.061
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
10.45
2-Sided
95
-0.37
21.30
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.283
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
6.31
2-Sided
95
-3.81
16.45
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.283
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
5.46
2-Sided
95
-3.39
14.31
No
Superiority or Other
52
OG00452
OG00552
21.30
(9.91 to 33.88)
OG00438.41(25.45 to 52.71)
OG005-18.36(-25.96 to -9.97)
Longitudinal Data Analysis
<.001
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
39.66
2-Sided
95
22.44
57.17
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis
0.003
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
20.68
2-Sided
95
5.72
35.78
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis
0.265
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
8.59
2-Sided
95
-4.81
22.05
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis
0.265
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
8.39
2-Sided
95
-3.40
20.21
No
Superiority or Other
52
OG00452
OG00552
25.79
(16.45 to 35.88)
OG00437.43(27.24 to 48.42)
OG005-15.62(-21.83 to -8.92)
Longitudinal Data Analysis Model
<0.001
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
41.41
2-Sided
95
27.36
55.65
No
Superiority or Other
OG002
OG005
Longitudinal Data Analysis Model
<0.001
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
24.81
2-Sided
95
12.39
37.33
No
Superiority or Other
OG001
OG005
Longitudinal Data Analysis Model
0.020
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.
LS Mean Difference in Change From BL
12.87
2-Sided
95
1.73
24.06
No
Superiority or Other
OG000
OG005
Longitudinal Data Analysis Model
0.397
The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.