A Phase II/III, Double-blind, Parallel Group Comparative... | NCT02063854 | Trialant
NCT02063854
Sponsor
Takeda
Status
Completed
Last Update Posted
Feb 23, 2017Actual
Enrollment
871Actual
Phase
Phase 2Phase 3
Conditions
Involutional Osteoporosis
Interventions
NE-58095 IR
NE-58095 IR Placebo
NE-58095 DR
NE-58095 DR Placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT02063854
Obsolete or Duplicate NCT IDs
NCT02066376
Organization Study
CCT-401
Secondary IDs
ID
Type
Description
Link
JapicCTI-142440
Registry Identifier
JapicCTI
U1111-1153-0440
Registry Identifier
WHO
NE-58095DR/CCT-401
Other Identifier
Takeda ID
Brief Title
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
Official Title
A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet (2.5 mg) for the Treatment of Involutional Osteoporosis
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Feb 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2014
Primary Completion Date
Nov 2015Actual
Completion Date
Nov 2015Actual
First Submitted Date
Feb 12, 2014
First Submission Date that Met QC Criteria
Feb 12, 2014
First Posted Date
Feb 14, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 16, 2016
Results First Submitted that Met QC Criteria
Feb 7, 2017
Results First Posted Date
Feb 23, 2017Actual
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 7, 2017
Last Update Posted Date
Feb 23, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TakedaINDUSTRY
Collaborators
Name
Class
EA Pharma Co., Ltd.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.
Detailed Description
The primary objective of the present study is to verify the non-inferiority of once-monthly oral administration of NE-58095 DR tablets for 12 months to once-daily oral administration of NE-58095 IR 2.5 mg tablets for 12 months, in terms of efficacy in participants with involutional osteoporosis.
Secondary objectives of the present study are as follows: to compare the safety of once-monthly oral administration of NE-58095 DR tablets for 12 months with the safety of once-daily oral administration of NE-58095 IR tablets (at 2.5 mg) for 12 months in participants with involutional osteoporosis at time of wakening.
Conditions Module
Conditions
Involutional Osteoporosis
Keywords
Drug Therapy
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 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
871Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
NE-58095 IR 2.5 mg Once Daily on Awakening
Active Comparator
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Drug: NE-58095 IR
Drug: NE-58095 DR Placebo
NE-58095 DR 25 mg Once Monthly on Awakening
Experimental
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Drug: NE-58095 IR Placebo
Drug: NE-58095 DR
Drug: NE-58095 DR Placebo
NE-58095 DR 25 mg Once Monthly Following Breakfast
Experimental
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Drug: NE-58095 IR Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
NE-58095 IR
Drug
NE-58095 IR tablets
NE-58095 IR 2.5 mg Once Daily on Awakening
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
Baseline and End of Study (up to Month 12)
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of involutional osteoporosis
Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent
Women for whom at least 2 years have passed since the last natural menstruation
Exclusion Criteria:
Patients with secondary osteoporosis
Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass
Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)
Patients with a history of radiotherapy to the lumbar spine or the pelvis
Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period
Patients with a history of treatment with any anti-receptor activator of nuclear factor-κB ligand (RANKL) monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period
Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period
Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period
Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding
Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus)
Patients with hypocalcemia
Patients with hypercalcemia
Patients with a diagnosis of renal calculus
Patients with serious renal, hepatic, or cardiac disease
Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director Clinical Science
Takeda
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Nagoya
Aichi-ken
Japan
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants with a diagnosis of involutional osteoporosis were randomized at a ratio of 3:1:3:1:1:3:1 into 1 of 7 treatment groups: once-daily NE-58095 2.5 mg immediate release (IR) or once-monthly NE-58095 25 mg or 37.5 mg delayed release (DR) on awakening, after breakfast or 30 minutes following breakfast.
Recruitment Details
Participants took part in the study at 67 investigative sites in Japan from 21 February 2014 to 19 November 2015.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
Experimental
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Drug: NE-58095 IR Placebo
Drug: NE-58095 DR
Drug: NE-58095 DR Placebo
NE-58095 DR 37.5 mg Once Monthly on Awakening
Experimental
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Drug: NE-58095 IR Placebo
Drug: NE-58095 DR
Drug: NE-58095 DR Placebo
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
Experimental
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Drug: NE-58095 IR Placebo
Drug: NE-58095 DR
Drug: NE-58095 DR Placebo
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
Experimental
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Drug: NE-58095 IR Placebo
Drug: NE-58095 DR
Drug: NE-58095 DR Placebo
NE-58095 IR Placebo
Drug
NE-58095 IR placebo-matching tablets
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR
Drug
NE-58095 DR tablets
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR Placebo
Drug
NE-58095 DR placebo-matching tablets
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 IR 2.5 mg Once Daily on Awakening
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra's height was reduced from the baseline by at least 20% and by at least 4 mm.
Baseline to Month 12
Chiba
Chiba
Japan
Narashino-shi
Chiba
Japan
Fukuoka
Fukuoka
Japan
Kitakyushu-shi
Fukuoka
Japan
Onga-gun
Fukuoka
Japan
Ebetsu-shi
Hokkaido
Japan
Sapporo
Hokkaido
Japan
Kako-gun
Hyōgo
Japan
Morioka
Iwate
Japan
Atsugi-shi
Kanagawa
Japan
Kawasaki-shi
Kanagawa
Japan
Yokohama
Kanagawa
Japan
Zushi-shi
Kanagawa
Japan
Kumamoto
Kumamoto
Japan
Tamana-shi
Kumamoto
Japan
Sendai
Miyagi
Japan
Tagajō-shi
Miyagi
Japan
Miyazaki
Miyazaki
Japan
Saito-shi
Miyazaki
Japan
Higashi Osaka-shi
Osaka
Japan
Saitama-shi
Saitama
Japan
Daito-ku
Tokyo
Japan
Setagaya-ku
Tokyo
Japan
Wakayama
Wakayama
Japan
FG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
FG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
FG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
FG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
FG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
FG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
FG000199 subjects
FG00166 subjects
FG002206 subjects
FG00368 subjects
FG00465 subjects
FG005201 subjects
FG00666 subjects
Full Analysis Set: Received Study Drug
FG000199 subjects
FG00166 subjects
FG002206 subjects
FG00368 subjects
FG00465 subjects
FG005200 subjects
FG00666 subjects
COMPLETED
FG000178 subjects
FG00154 subjects
FG002176 subjects
FG00358 subjects
FG00454 subjects
FG005170 subjects
FG00660 subjects
NOT COMPLETED
FG00021 subjects
FG00112 subjects
FG00230 subjects
FG00310 subjects
FG00411 subjects
FG00531 subjects
FG0066 subjects
Type
Comment
Reasons
Pretreatment Event/Adverse Event
FG00013 subjects
FG00110 subjects
FG00213 subjects
FG0038 subjects
FG0047 subjects
FG00518 subjects
FG0064 subjects
Major Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Voluntary Withdrawal
FG0002 subjects
FG0010 subjects
FG0028 subjects
FG0031 subjects
FG004
Surgical Dental Work Performed/Planned
FG0005 subjects
FG0012 subjects
FG0026 subjects
FG0031 subjects
FG004
Reason Not Specified
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Did Not Receive Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized set included all participants who were randomized to the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
BG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
BG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
BG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
BG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
BG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
BG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000199
BG00166
BG002206
BG00368
BG00465
BG005201
BG00666
BG007871
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00068.9± 7.32
BG00169.0± 8.18
BG00268.2± 7.68
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000190
BG00164
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Japan
Title
Measurements
BG000199
BG00166
BG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000152.1± 6.59
BG001151.0± 6.64
BG002
Weight
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00050.52± 7.975
BG00149.98± 6.720
Body Mass Index (BMI)
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00021.82± 3.009
BG00121.93± 2.830
Smoking Classification
Number
participants
Title
Denominators
Categories
Never smoked
Title
Measurements
BG000167
BG00155
BG002
Menopausal Status
Female participants only (N=190, 64, 203, 66, 63, 198, 63).
Number
participants
Title
Denominators
Categories
Natural Menopause
Title
Measurements
BG000170
BG00158
BG002
Number of Years After Menopause, Categorical
Female participants only (N=190, 64, 203, 66, 63, 198, 63).
Number
participants
Title
Denominators
Categories
Min - ≤5 years
Title
Measurements
BG0006
BG0015
BG002
Number of Years After Menopause
Data was available for 152, 52, 159, 56, 54, 162 and 51 female participants in each treatment arm, respectively.
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00018.6± 7.81
BG00120.2± 8.72
History of Bisphosphonate Administration
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00019
BG0016
BG002
Timing of Initial Delayed Release (DR) Tablet Administration on Awakening
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Number
participants
Title
Denominators
Categories
Less than 30 Minutes before Breakfast
Title
Measurements
BG0000
BG0010
Lumbar Spine (L2-L4) Bone Mineral Density (BMD), Categorical
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively. YAM=young adult mean (20 to 44 years age range).
Number
participants
Title
Denominators
Categories
Min - ≤0.707 g/cm^2
Title
Measurements
BG000167
BG001
L2-L4 (BMD)
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
g/cm^2
Title
Denominators
Categories
Title
Measurements
BG0000.6553± 0.09060
BG0010.6690± 0.11746
L2-L4 BMD T-score, Categorical
BMD T-score is a comparison of an individual's BMD compared to "normal". Also, BMD T-score is the standard deviation of the difference between measured BMD and that of the healthy young adult "normal". The T-score scale is as follows: -1 and above=normal, -1 to -2.5=osteopenia (below normal and may lead to osteoporosis), and -2.5 and below=osteoporosis.
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Number
participants
Title
Denominators
Categories
Min - ≤-2.500
Title
Measurements
BG000169
BG001
L2-L4 BMD T-score
BMD T-score is a comparison of an individual's BMD compared to "normal". Also, BMD T-score is the standard deviation of the difference between measured BMD and that of the healthy young adult "normal". The T-score scale is as follows: -1 and above=normal, -1 to -2.5=osteopenia (below normal and may lead to osteoporosis), and -2.5 and below=osteoporosis. Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
Title
Measurements
BG000-2.9889± 0.76130
BG001
Total Proximal Femur BMD
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
g/cm^2
Title
Denominators
Categories
Title
Measurements
BG0000.6553± 0.08997
BG0010.6573± 0.09537
Total Proximal Femur BMD T-score
BMD T-score is a comparison of an individual's BMD compared to "normal". Also, BMD T-score is the standard deviation of the difference between measured BMD and that of the healthy young adult "normal". The T-score scale is as follows: -1 and above=normal, -1 to -2.5=osteopenia (below normal and may lead to osteoporosis), and -2.5 and below=osteoporosis. Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
Title
Measurements
BG000-2.1972± 0.89971
BG001
Trochanter BMD
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
g/cm^2
Title
Denominators
Categories
Title
Measurements
BG0000.4938± 0.07793
BG0010.4954± 0.06803
Femoral Neck BMD
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
g/cm^2
Title
Denominators
Categories
Title
Measurements
BG0000.5318± 0.07695
BG0010.5258± 0.08147
Femoral Neck BMD T-score
BMD T-score is a comparison of an individual's BMD compared to "normal". Also, BMD T-score is the standard deviation of the difference between measured BMD and that of the healthy young adult "normal". The T-score scale is as follows: -1 and above=normal, -1 to -2.5=osteopenia (below normal and may lead to osteoporosis), and -2.5 and below=osteoporosis. Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Number
participants
Title
Denominators
Categories
0
Title
Measurements
BG000138
BG00132
Fragility Fracture
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG00086
BG00137
BG002
Primary Osteoporosis Diagnosis Criteria 2012
Data was available for 199, 66, 206, 67, 65, 201 and 66 participants in each treatment arm, respectively. YAM=young adult mean (lumbar spine: 20 to 44 years age range, proximal femur: 20 to 29 years age range).
Number
participants
Title
Denominators
Categories
Fragility Fracture (Vertebrae or Proximal Femur)
Title
Measurements
BG00065
BG001
Serum 25-hydroxy Vitamin D (25-OH-D), Categorical
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Number
participants
Title
Denominators
Categories
Min - ≤14.9 ng/mL
Title
Measurements
BG00018
BG0018
Serum 25-OH-D
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
ng/mL
Title
Denominators
Categories
Title
Measurements
BG00021.55± 5.266
BG00121.44± 5.423
Serum C-telopeptide of Type 1 Collagen (CTX)
Data was available for 199, 66, 205, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
ng/mL
Title
Denominators
Categories
Title
Measurements
BG0000.444± 0.1660
BG0010.460
Serum Bone-type Alkaline Phosphatase (BAP)
Data was available for 199, 66, 205, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Data was available for 199, 66, 205, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
mU/dL
Title
Denominators
Categories
Title
Measurements
BG000427.1± 154.67
BG001424.1
Serum Procollagen 1 N-terminal Peptide (P1NP)
Data was available for 198, 66, 206, 68, 64, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
μg/L
Title
Denominators
Categories
Title
Measurements
BG00051.79± 20.357
BG00154.91
Urine Type 1 Collagen Cross-linked N-telopeptide (NTX)
Data was available for 199, 66, 206, 68, 65, 200 and 66 participants in each treatment arm, respectively.
Mean
Standard Deviation
nmol BCE/mmol-CRE
Title
Denominators
Categories
Title
Measurements
BG00056.76± 26.169
BG001
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
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
Full Analysis Set (FAS), all randomized participants who received at least 1 dose of study drug, with data available for analyses.
Posted
Mean
Standard Deviation
percent change
Baseline and End of Study (up to Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG002
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000190
OG001194
OG002181
Title
Denominators
Categories
Title
Measurements
OG0005.07± 4.749
OG0013.36± 4.332
OG0024.11± 4.654
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
t-test, 1 sided
With a non-inferiority margin (Δ) of 1.5%.
0.1346
Non-Inferiority or Equivalence
Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.
OG000
OG001
Secondary
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. "n" in the category is the number of participants with data available at the given time-point.
Posted
Mean
Standard Deviation
percent change
Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Secondary
Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra's height was reduced from the baseline by at least 20% and by at least 4 mm.
FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.
Posted
Number
percentage of participants
Baseline to Month 12
ID
Title
Description
OG000
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Time Frame
First dose of study drug to 30 days past last dose of study drug (Up to 13 Months)
Description
At each visit the investigator documented any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of relation to study treatment. AEs were monitored until the participant recovered or investigator judged no further follow-up was needed.
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
NE-58095 IR 2.5 mg Once Daily on Awakening
NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
12
199
128
199
EG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
5
66
43
66
EG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
11
206
132
206
EG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
7
68
43
68
EG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
2
65
46
65
EG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
8
200
138
200
EG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
3
66
42
66
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure congestive
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0011 affected66 at risk
EG0020 affected206 at risk
EG0030 affected68 at risk
EG0040 affected65 at risk
EG0050 affected200 at risk
EG0060 affected66 at risk
Angina pectoris
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Meniere's disease
Ear and labyrinth disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Goitre
Endocrine disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Cataract
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0002 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Drowning
General disorders
MedDRA 18.1
Systematic Assessment
One treatment-emergent death occurred during treatment in NE-58095 DR 37.5 mg Once Monthly Following Breakfast group and is not related to study drug.
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Mycobacterial infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0003 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0011 affected66 at risk
EG0020 affected206 at risk
EG003
Accident
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Muscle contusion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0011 affected66 at risk
EG0020 affected206 at risk
EG003
Hyperammonaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Gastric cancer stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Malignant neoplasm of renal pelvis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0011 affected66 at risk
EG0020 affected206 at risk
EG003
Soft tissue neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Brain stem infarction
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Dementia Alzheimer's type
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0011 affected66 at risk
EG0020 affected206 at risk
EG003
Ovarian cyst torsion
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0011 affected66 at risk
EG0020 affected206 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0011 affected66 at risk
EG0020 affected206 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0010 affected66 at risk
EG0020 affected206 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 affected199 at risk
EG0011 affected66 at risk
EG0020 affected206 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dry eye
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0002 affected199 at risk
EG0013 affected66 at risk
EG0023 affected206 at risk
EG0030 affected68 at risk
EG0044 affected65 at risk
EG0051 affected200 at risk
EG0060 affected66 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0009 affected199 at risk
EG0012 affected66 at risk
EG00215 affected206 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG00010 affected199 at risk
EG0014 affected66 at risk
EG00212 affected206 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0003 affected199 at risk
EG0013 affected66 at risk
EG00214 affected206 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0022 affected206 at risk
EG003
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0011 affected66 at risk
EG0029 affected206 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0010 affected66 at risk
EG0022 affected206 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG00064 affected199 at risk
EG00119 affected66 at risk
EG00251 affected206 at risk
EG003
Cystitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0002 affected199 at risk
EG0012 affected66 at risk
EG0028 affected206 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0001 affected199 at risk
EG0012 affected66 at risk
EG0025 affected206 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG00021 affected199 at risk
EG0017 affected66 at risk
EG00213 affected206 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG00016 affected199 at risk
EG0015 affected66 at risk
EG00210 affected206 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0008 affected199 at risk
EG0012 affected66 at risk
EG0028 affected206 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0005 affected199 at risk
EG0012 affected66 at risk
EG0025 affected206 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG00014 affected199 at risk
EG0011 affected66 at risk
EG00216 affected206 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0004 affected199 at risk
EG0013 affected66 at risk
EG00213 affected206 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0005 affected199 at risk
EG0014 affected66 at risk
EG0028 affected206 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0008 affected199 at risk
EG0013 affected66 at risk
EG0025 affected206 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0002 affected199 at risk
EG0010 affected66 at risk
EG0021 affected206 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0003 affected199 at risk
EG0011 affected66 at risk
EG00210 affected206 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0009 affected199 at risk
EG0013 affected66 at risk
EG00210 affected206 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG00010 affected199 at risk
EG0013 affected66 at risk
EG00211 affected206 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0002 affected199 at risk
EG0011 affected66 at risk
EG0027 affected206 at risk
EG003
The collaborator company name EA Pharma Co., Ltd. has been changed from 1st April 2016. The legacy name was Ajinomoto Pharmaceutics Co., Ltd.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Director
Takeda
+1-877-825-3327
trialdisclosures@takeda.com
ID
Term
D010024
Osteoporosis
Ancestor Terms
ID
Term
D001851
Bone Diseases, Metabolic
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG0056 subjects
FG0061 subjects
1 subjects
FG0056 subjects
FG0061 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0051 subjects
FG0060 subjects
68.4
± 7.24
BG00469.0± 6.98
BG00569.6± 7.19
BG00669.8± 7.87
BG00768.9± 7.45
203
BG00366
BG00463
BG005198
BG00663
BG007847
Male
BG0009
BG0012
BG0023
BG0032
BG0042
BG0053
BG0063
BG00724
206
BG00368
BG00465
BG005201
BG00666
BG007871
151.9
± 6.11
BG003152.5± 5.49
BG004153.5± 5.13
BG005151.3± 5.20
BG006151.9± 6.47
BG007151.9± 6.00
BG00250.20± 7.231
BG00350.97± 8.736
BG00451.26± 7.473
BG00550.36± 7.383
BG00650.51± 7.427
BG00750.46± 7.544
BG00221.75± 2.926
BG00321.97± 3.875
BG00421.79± 3.289
BG00522.00± 3.105
BG00621.90± 3.071
BG00721.87± 3.092
178
BG00353
BG00454
BG005168
BG00658
BG007733
Current smoker
Title
Measurements
BG00010
BG0014
BG00211
BG0033
BG0043
BG0057
BG0063
BG00741
Ex-smoker
Title
Measurements
BG00022
BG0017
BG00217
BG00312
BG0048
BG00526
BG0065
BG00797
179
BG00360
BG00453
BG005180
BG00659
BG007759
Artificial Menopause
Title
Measurements
BG00020
BG0016
BG00224
BG0036
BG00410
BG00518
BG0064
BG00788
7
BG0034
BG0043
BG0054
BG0062
BG00731
6 - ≤10 years
Title
Measurements
BG00023
BG0011
BG00228
BG0034
BG0048
BG00522
BG0066
BG00792
11 - ≤20 years
Title
Measurements
BG00059
BG00121
BG00271
BG00329
BG00420
BG00561
BG00620
BG007281
21 - ≤30 years
Title
Measurements
BG00055
BG00119
BG00242
BG00312
BG00419
BG00558
BG00619
BG007224
≥31 years
Title
Measurements
BG0009
BG0016
BG00211
BG0037
BG0044
BG00517
BG0064
BG00758
Unknown, But >2 years
Title
Measurements
BG00038
BG00112
BG00244
BG00310
BG0049
BG00536
BG00612
BG007161
BG00217.2± 8.44
BG00318.3± 8.28
BG00419.2± 8.36
BG00519.5± 8.41
BG00620.1± 7.84
BG00718.7± 8.28
24
BG0038
BG0049
BG00526
BG0066
BG00798
No
Title
Measurements
BG000180
BG00160
BG002182
BG00360
BG00456
BG005175
BG00660
BG007773
BG0020
BG0030
BG0040
BG0051
BG0060
BG0071
0.5 to 1.5 Hours before Breakfast
Title
Measurements
BG000165
BG00156
BG002167
BG00352
BG00453
BG005164
BG00650
BG007707
1.5 to 2.5 Hours before Breakfast
Title
Measurements
BG00029
BG0018
BG00235
BG00313
BG0048
BG00527
BG00615
BG007135
2.5 to 4 Hours before Breakfast
Title
Measurements
BG0005
BG0012
BG0024
BG0033
BG0044
BG0058
BG0061
BG00727
46
BG002176
BG00354
BG00452
BG005158
BG00649
BG007702
0.708 (70%YAM) - ≤0.808 g/cm^2
Title
Measurements
BG00024
BG00113
BG00221
BG00311
BG00410
BG00528
BG00611
BG007118
0.809 (80%YAM) g/cm^2 - ≤Max
Title
Measurements
BG0008
BG0017
BG0029
BG0033
BG0043
BG00514
BG0066
BG00750
BG0020.6477± 0.08037
BG0030.6633± 0.08766
BG0040.6448± 0.08909
BG0050.6589± 0.09893
BG0060.6714± 0.09999
BG0070.6564± 0.09303
47
BG002177
BG00354
BG00453
BG005160
BG00651
BG007711
-2.499 - ≤-1.000
Title
Measurements
BG00028
BG00116
BG00226
BG00312
BG00412
BG00536
BG00612
BG007142
-0.999 - ≤Max
Title
Measurements
BG0002
BG0013
BG0023
BG0032
BG0040
BG0054
BG0063
BG00717
-2.8738
± 0.98709
BG002-3.0532± 0.67537
BG003-2.9219± 0.73670
BG004-3.0773± 0.74863
BG005-2.9587± 0.83135
BG006-2.8536± 0.84030
BG007-2.9796± 0.78178
BG0020.6452± 0.08490
BG0030.6580± 0.07982
BG0040.6486± 0.06973
BG0050.6652± 0.08465
BG0060.6520± 0.07289
BG0070.6548± 0.08464
-2.1770
± 0.95369
BG002-2.2982± 0.84903
BG003-2.1699± 0.79822
BG004-2.2642± 0.69731
BG005-2.0978± 0.84652
BG006-2.2305± 0.72892
BG007-2.2021± 0.84645
BG0020.4844± 0.06610
BG0030.4932± 0.07164
BG0040.4879± 0.05653
BG0050.5009± 0.06626
BG0060.4900± 0.06824
BG0070.4925± 0.06914
BG0020.5278± 0.07960
BG0030.5348± 0.07154
BG0040.5245± 0.06293
BG0050.5411± 0.08051
BG0060.5373± 0.07346
BG0070.5327± 0.07712
-2.9358
± 0.90523
BG002-2.9135± 0.88448
BG003-2.8360± 0.79487
BG004-2.9501± 0.69920
BG005-2.7652± 0.89454
BG006-2.8077± 0.81618
BG007-2.8594± 0.85690
14
BG0035
BG0046
BG00512
BG0066
BG00762
Delphi
Title
Measurements
BG00028
BG0019
BG00229
BG0039
BG0049
BG00526
BG0068
BG007118
Discovery
Title
Measurements
BG000114
BG00138
BG002120
BG00339
BG00435
BG005118
BG00635
BG007499
Explorer
Title
Measurements
BG00043
BG00114
BG00243
BG00315
BG00415
BG00545
BG00617
BG007192
BG002
125
BG00342
BG00438
BG005121
BG00635
BG007531
1
Title
Measurements
BG00039
BG00121
BG00261
BG00317
BG00418
BG00558
BG00625
BG007239
2
Title
Measurements
BG00012
BG0018
BG00212
BG0037
BG0046
BG00515
BG0066
BG00766
≥3
Title
Measurements
BG00010
BG0015
BG0028
BG0032
BG0043
BG0056
BG0060
BG00734
91
BG00332
BG00431
BG005104
BG00636
BG007417
No
Title
Measurements
BG000113
BG00129
BG002115
BG00336
BG00434
BG00597
BG00630
BG007454
30
BG00282
BG00329
BG00425
BG00580
BG00632
BG007343
Fragility Fracture (Other and BMD<YAM*80%)
Title
Measurements
BG00021
BG0017
BG0029
BG0033
BG0046
BG00524
BG0064
BG00774
No Fragility Fracture and BMD<=YAM*70%
Title
Measurements
BG000113
BG00129
BG002115
BG00335
BG00434
BG00597
BG00630
BG007453
BG002
21
BG0035
BG0048
BG00521
BG0068
BG00789
15.0 - ≤27.9 ng/mL
Title
Measurements
BG000161
BG00151
BG002157
BG00353
BG00450
BG005160
BG00653
BG007685
28.0 ng/mL - ≤Max
Title
Measurements
BG00020
BG0017
BG00228
BG00310
BG0047
BG00519
BG0065
BG00796
BG00221.46± 5.592
BG00321.64± 5.427
BG00421.17± 5.248
BG00521.52± 5.121
BG00620.58± 4.761
BG00721.42± 5.288
± 0.1855
BG0020.426± 0.1776
BG0030.421± 0.1437
BG0040.497± 0.1867
BG0050.417± 0.1592
BG0060.399± 0.1613
BG0070.434± 0.1696
± 8.617
BG00215.83± 6.035
BG00315.45± 5.024
BG00417.17± 7.354
BG00515.13± 5.164
BG00615.13± 6.815
BG00715.79± 6.142
± 144.89
BG002422.1± 162.07
BG003398.4± 127.54
BG004444.7± 142.90
BG005410.5± 142.09
BG006395.0± 128.38
BG007418.5± 148.29
± 27.552
BG00250.89± 22.635
BG00347.83± 17.120
BG00453.43± 22.783
BG00548.53± 20.366
BG00646.04± 21.714
BG00750.44± 21.648
61.04
± 34.808
BG00254.98± 23.928
BG00353.77± 22.739
BG00464.44± 29.535
BG00554.48± 23.988
BG00653.66± 23.911
BG00756.24± 25.871
t-test, 1 sided
With a non-inferiority margin (Δ) of 1.5%.
0.6711
Non-Inferiority or Equivalence
Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.
OG000
OG002
Mean Difference (Final Values)
-0.96
2-Sided
95
-1.920
0.001
Superiority or Other
OG000
OG001
Mean Difference (Final Values)
-1.71
2-Sided
95
-2.617
-0.794
Superiority or Other
OG001
OG002
Mean Difference (Final Values)
0.75
2-Sided
95
-0.166
1.658
Superiority or Other
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 6 (n=190, 62, 194, 61, 59, 181, 63)
Title
Measurements
OG0003.18± 4.211
OG0011.73± 3.635
OG0021.92± 4.124
OG0032.40± 3.408
OG0043.67± 4.841
OG0052.70± 4.117
OG0062.64± 4.907
Month 12 (n=178, 58, 180, 58, 55, 171, 60)
Title
Measurements
OG0005.00± 4.783
OG0013.83± 4.227
OG0023.53± 4.423
OG003
End of Study (n=190, 62, 194, 61, 59, 181, 63)
Title
Measurements
OG0005.07± 4.749
OG0013.82± 4.158
OG0023.36± 4.332
OG003
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 6 (n=189, 62, 194, 61, 59, 180, 63)
Title
Measurements
OG0001.10± 2.782
OG0010.91± 2.665
OG0020.43± 2.666
OG0030.54± 2.404
OG0040.77± 2.401
OG0050.78± 2.420
OG0060.55± 2.390
Month 12 (n=181, 58, 180, 59, 55, 172, 61)
Title
Measurements
OG0002.01± 3.316
OG0011.32± 3.399
OG0020.95± 3.233
OG003
End of Study (n=189, 62, 194, 61, 59, 180, 63)
Title
Measurements
OG0001.96± 3.288
OG0011.30± 3.309
OG0020.89± 3.172
OG003
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 6 (n=189, 62, 194, 61, 59, 180, 63)
Title
Measurements
OG0001.34± 4.854
OG0011.57± 3.832
OG0020.70± 4.324
OG0030.80± 3.500
OG0041.46± 3.495
OG0051.09± 3.141
OG0060.53± 4.432
Month 12 (n=181, 58, 180, 59, 55, 172, 61)
Title
Measurements
OG0002.59± 6.007
OG0011.80± 4.030
OG0021.36± 4.632
OG003
End of Study (n=189, 62, 194, 61, 59, 180, 63)
Title
Measurements
OG0002.52± 5.938
OG0011.67± 3.951
OG0021.35± 4.551
OG003
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 6 (n=189, 62, 194, 61, 59, 180, 63)
Title
Measurements
OG0001.07± 3.406
OG0010.90± 3.903
OG0020.71± 4.205
OG0030.49± 3.804
OG0041.01± 3.732
OG0050.57± 3.572
OG0060.67± 2.770
Month 12 (n=181, 58, 180, 59, 55, 172, 61)
Title
Measurements
OG0002.00± 4.010
OG0010.78± 4.302
OG0021.34± 4.687
OG003
End of Study (n=189, 62, 194, 61, 59, 180, 63)
Title
Measurements
OG0001.96± 4.017
OG0010.99± 4.451
OG0021.30± 4.638
OG003
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 1 (n=199, 66, 204, 68, 65, 200, 66)
Title
Measurements
OG000-41.02± 27.396
OG001-17.42± 27.978
OG002-15.53± 26.107
OG003-18.80± 25.956
OG004-33.52± 24.667
OG005-24.74± 28.675
OG006-19.34± 28.442
Month 3 (n=193, 63, 193, 65, 60, 184, 63)
Title
Measurements
OG000-47.79± 25.044
OG001-29.29± 22.794
OG002-24.80± 31.118
OG003
Month 6 (n=188, 61, 190, 60, 58, 178, 63)
Title
Measurements
OG000-52.42± 22.926
OG001-36.97± 29.126
OG002-24.39± 38.994
OG003
Month 9 (n=185, 60, 185, 59, 55, 175, 61)
Title
Measurements
OG000-52.44± 26.256
OG001-33.61± 27.438
OG002-16.75± 83.047
OG003
Month 12 (n=181, 55, 178, 59, 54, 170, 60)
Title
Measurements
OG000-48.98± 28.051
OG001-32.11± 32.662
OG002-16.42± 64.139
OG003
End of Study (n=199, 66, 204, 68, 65, 200, 66)
Title
Measurements
OG000-47.61± 28.275
OG001-29.94± 36.896
OG002-16.27± 60.895
OG003
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 1 (n=199, 66, 205, 68, 65, 200, 66)
Title
Measurements
OG000-3.04± 11.881
OG001-2.93± 13.365
OG002-2.61± 11.351
OG003-3.61± 12.135
OG004-4.16± 13.493
OG005-3.69± 13.142
OG006-2.44± 10.662
Month 3 (n=193, 63, 193, 65, 60, 184, 63)
Title
Measurements
OG000-21.56± 15.047
OG001-13.64± 18.499
OG002-13.31± 17.846
OG003
Month 6 (n=188, 61, 190, 60, 58, 178, 63)
Title
Measurements
OG000-28.66± 19.087
OG001-20.92± 23.433
OG002-17.93± 21.202
OG003
Month 9 (n=185, 61, 185, 59, 55, 175, 61)
Title
Measurements
OG000-32.84± 17.700
OG001-25.23± 24.949
OG002-22.48± 22.233
OG003
Month 12 (n=181, 55, 178, 59, 54, 170, 60)
Title
Measurements
OG000-34.53± 20.506
OG001-29.23± 22.721
OG002-24.91± 21.537
OG003
End of Study (n=199, 66, 205, 68, 65, 200, 66)
Title
Measurements
OG000-33.34± 21.428
OG001-26.27± 24.287
OG002-23.11± 21.553
OG003
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 1 (n=199, 66, 205, 68, 65, 200, 66)
Title
Measurements
OG000-32.38± 17.664
OG001-17.26± 20.728
OG002-17.49± 19.406
OG003-21.05± 17.749
OG004-30.75± 19.626
OG005-25.20± 19.726
OG006-22.06± 20.097
Month 3 (n=193, 63, 193, 65, 60, 184, 63)
Title
Measurements
OG000-37.27± 17.105
OG001-25.46± 18.567
OG002-23.85± 22.714
OG003
Month 6 (n=188, 61, 190, 60, 58, 178, 63)
Title
Measurements
OG000-39.48± 17.702
OG001-29.15± 21.223
OG002-23.87± 27.077
OG003
Month 9 (n=185, 61, 185, 59, 55, 175, 61)
Title
Measurements
OG000-37.64± 19.734
OG001-25.82± 24.762
OG002-19.44± 45.595
OG003
Month 12 (n=181, 55, 178, 59, 54, 170, 60)
Title
Measurements
OG000-34.91± 20.628
OG001-23.70± 25.425
OG002-13.25± 63.783
OG003
End of Study (n=199, 66, 205, 68, 65, 200, 66)
Title
Measurements
OG000-34.76± 20.602
OG001-22.93± 26.532
OG002-13.86± 60.015
OG003
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 1 (n=196, 66, 206, 68, 64, 200, 66)
Title
Measurements
OG000-6.55± 17.134
OG001-9.08± 16.765
OG002-7.70± 15.206
OG003-9.73± 16.472
OG004-13.68± 16.892
OG005-9.86± 14.908
OG006-10.07± 15.969
Month 3 (n=192, 63, 194, 64, 59, 184, 63)
Title
Measurements
OG000-45.59± 19.379
OG001-32.19± 27.464
OG002-29.09± 26.955
OG003
Month 6 (n=187, 61, 191, 60, 57, 178, 63)
Title
Measurements
OG000-50.83± 22.450
OG001-39.51± 27.766
OG002-33.02± 35.354
OG003
Month 9 (n=184, 61, 186, 59, 54, 175, 61)
Title
Measurements
OG000-46.82± 29.820
OG001-34.80± 29.523
OG002-27.74± 38.273
OG003
Month 12 (n=180, 55, 179, 59, 53, 170, 60)
Title
Measurements
OG000-42.90± 31.614
OG001-35.65± 27.158
OG002-25.32± 36.833
OG003
End of Study (n=198, 66, 206, 68, 64, 200, 66)
Title
Measurements
OG000-41.93± 31.952
OG001-32.03± 31.584
OG002-25.51± 35.324
OG003
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
Units
Counts
Participants
OG000199
OG00166
OG002206
OG00368
OG00465
OG005200
OG00666
Title
Denominators
Categories
Month 1 (n=199, 66, 206, 68, 65, 200, 66)
Title
Measurements
OG000-32.73± 29.296
OG001-11.79± 38.228
OG002-12.42± 35.178
OG003-17.15± 40.458
OG004-29.81± 29.087
OG005-16.42± 39.131
OG006-12.64± 42.198
Month 3 (n=193, 63, 194, 65, 60, 184, 63)
Title
Measurements
OG000-37.94± 30.360
OG001-22.32± 35.861
OG002-15.64± 39.676
OG003
Month 6 (n=188, 61, 191, 60, 58, 178, 63)
Title
Measurements
OG000-35.00± 35.405
OG001-29.69± 37.178
OG002-7.96± 52.202
OG003
Month 9 (n=185, 61, 186, 59, 55, 175, 61)
Title
Measurements
OG000-30.97± 38.541
OG001-17.23± 38.383
OG002-7.71± 50.697
OG003
Month 12 (n=181, 55, 179, 59, 54, 170, 60)
Title
Measurements
OG000-35.64± 37.715
OG001-27.45± 33.172
OG002-4.66± 61.863
OG003
End of Study (n=199, 66, 206, 68, 65, 200, 66)
Title
Measurements
OG000-35.30± 37.274
OG001-25.83± 32.786
OG002-4.72± 59.237
OG003
OG001
NE-58095 DR 25 mg Once Monthly on Awakening
NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG002
NE-58095 DR 25 mg Once Monthly Following Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG003
NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG004
NE-58095 DR 37.5 mg Once Monthly on Awakening
NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG005
NE-58095 DR 37.5 mg Once Monthly Following Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
OG006
NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast
NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.