A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis

Study Overview
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Brief Summary
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The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis

Conditions
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Postmenopausal Osteoporosis

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 Korean women, ≥ 55 to ≤ 90 years of age at enrollment. Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening. BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck. At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA. Other inclusion criteria may apply. Exclusion Criteria: Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck. History of hip fracture. Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities. Known sensitivity or intolerance calcium and vitamin D products. Other exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received placebo subcutaneous injection once a month for 6 months. | Drug: Placebo<br>* Administered by subcutaneous injections once a month<br>|
| Experimental: Romosozumab<br>Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months. | Drug: Romosozumab<br>* Administered by subcutaneous injection once a month (QM)<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 Month 6 in Bone Mineral Density at the Lumbar Spine | Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Baseline and month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip | Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Baseline and month 6 | 
| Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck | Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader. | Baseline and month 6 | 

 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.