Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.

Official Title
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A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: AMG 162
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria - Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Ages Eligible for Study
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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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 162<br>60 mg/mL denosumab given day 1, month 6, month 12 and month 18 | Drug: AMG 162<br>* 60 mg/mL denosumab given day 1, month 6, month 12 and month 18<br>|
| Placebo Comparator: Placebo<br>Placebo given day 1, month 6, month 12 and month 18 | Drug: Placebo<br>* Placebo given at day 1, month 6, month 12 and month 18<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 24 Months | 
| Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 24 Months | 
| Trochanter Bone Mineral Density Percent Change From Baseline at Month 24 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 24 months | 
| Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 24 months | 
| Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 24 months | 
| Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT). | 24 months | 
| Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT). | 24 months | 
| Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24 | Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT). | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Postmenopausal