Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.

Official Title
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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

Conditions
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Postmenopausal Osteoporosis (PMO)

Intervention / Treatment
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* Drug: Romosozumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months. | Drug: Placebo<br>* Administered by subcutaneous injection<br>|
| Experimental: Romosozumab 70 mg<br>Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months. | Drug: Romosozumab<br>* Administered by subcutaneous injection<br>* Other names: EVENITY™;|
| Experimental: Romosozumab 140 mg<br>Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months. | Drug: Romosozumab<br>* Administered by subcutaneous injection<br>* Other names: EVENITY™;|
| Experimental: Romosozumab 210 mg<br>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. | Drug: Romosozumab<br>* Administered by subcutaneous injection<br>* Other names: EVENITY™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine | 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 | 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 | 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 | 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 | 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 | 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 | 
| Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) |  | Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 | 
| Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) |  | Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 | 
| Percent Change From Baseline in Osteocalcin |  | Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 | 
| Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) |  | Baseline, week 1, and months 1, 2, 3, 6, 9, and 12 | 
| Area Under the Curve Through Month 12 of P1NP |  | Baseline, week 1 and months 1, 2, 3, 6, 9, and 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases