- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01992159
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
March 21, 2019 updated by: Amgen
A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
252
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi
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Anjyo-shi, Aichi, Japan, 446-0063
- Research Site
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 814-0165
- Research Site
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Kitakyushu-shi, Fukuoka, Japan, 800-0057
- Research Site
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Yanagawa-shi, Fukuoka, Japan, 832-0059
- Research Site
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Gifu
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Mizunami-shi, Gifu, Japan, 509-6134
- Research Site
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Hokkaido
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Sapporo-shi, Hokkaido, Japan, 063-0814
- Research Site
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Sapporo-shi, Hokkaido, Japan, 065-0024
- Research Site
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Iwate
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Morioka-shi, Iwate, Japan, 020-0066
- Research Site
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Kanagawa
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Yokohama-shi, Kanagawa, Japan, 223-0062
- Research Site
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Yokohama-shi, Kanagawa, Japan, 231-0861
- Research Site
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Kyoto
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Kyoto-shi, Kyoto, Japan, 602-8026
- Research Site
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Miyagi
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Sendai-shi, Miyagi, Japan, 981-3132
- Research Site
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Sendai-shi, Miyagi, Japan, 983-0862
- Research Site
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Miyazaki
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Saito-shi, Miyazaki, Japan, 881-0113
- Research Site
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Nagano
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Matsumoto-shi, Nagano, Japan, 390-1401
- Research Site
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Ueda-shi, Nagano, Japan, 386-0151
- Research Site
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Ueda-shi, Nagano, Japan, 386-0405
- Research Site
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Osaka
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Osaka-shi, Osaka, Japan, 559-0011
- Research Site
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Takatsuki-shi, Osaka, Japan, 569-1123
- Research Site
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Saitama
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Kita-adachi-gun, Saitama, Japan, 362-0806
- Research Site
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Tokyo
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Hachioji-shi, Tokyo, Japan, 192-0046
- Research Site
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Kiyose-shi, Tokyo, Japan, 204-0021
- Research Site
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Minato-ku, Tokyo, Japan, 108-0075
- Research Site
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Ota-ku, Tokyo, Japan, 146-0094
- Research Site
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Shinagawa-ku, Tokyo, Japan, 140-0011
- Research Site
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Suginami-ku, Tokyo, Japan, 166-0003
- Research Site
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Toshima-ku, Tokyo, Japan, 171-0033
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)
Exclusion Criteria:
- Severe osteoporosis
- Use of agents affecting bone metabolism
- History of metabolic or bone disease (except osteoporosis)
- Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.
|
Administered by subcutaneous injection
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Experimental: Romosozumab 70 mg
Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.
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Administered by subcutaneous injection
Other Names:
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Experimental: Romosozumab 140 mg
Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.
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Administered by subcutaneous injection
Other Names:
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Experimental: Romosozumab 210 mg
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
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Administered by subcutaneous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine
Time Frame: Baseline and 12 months
|
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA).
DXA scans were analyzed by a central imaging reader.
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine
Time Frame: Baseline and 6 months
|
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA).
DXA scans were analyzed by a central imaging reader.
|
Baseline and 6 months
|
Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip
Time Frame: Baseline and 6 months
|
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA).
DXA scans were analyzed by a central imaging reader.
|
Baseline and 6 months
|
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip
Time Frame: Baseline and 12 months
|
Bone density was measured using dual-energy X-ray absorptiometry (DXA).
DXA scans were analyzed by a central imaging reader.
|
Baseline and 12 months
|
Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck
Time Frame: Baseline and 6 months
|
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA).
DXA scans were analyzed by a central imaging reader.
|
Baseline and 6 months
|
Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck
Time Frame: Baseline and 12 months
|
Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA).
DXA scans were analyzed by a central imaging reader.
|
Baseline and 12 months
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Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)
Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
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Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
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Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)
Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
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Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
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Percent Change From Baseline in Osteocalcin
Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
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Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
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Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)
Time Frame: Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
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Baseline, week 1, and months 1, 2, 3, 6, 9, and 12
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Area Under the Curve Through Month 12 of P1NP
Time Frame: Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.
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Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2012
Primary Completion (Actual)
October 9, 2014
Study Completion (Actual)
June 17, 2015
Study Registration Dates
First Submitted
November 19, 2013
First Submitted That Met QC Criteria
November 19, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Actual)
March 25, 2019
Last Update Submitted That Met QC Criteria
March 21, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20101291
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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