An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

Study Overview
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Brief Summary
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An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Official Title
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An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density

Conditions
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Low Bone Mineral Density

Intervention / Treatment
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* Drug: AMG 162


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be ambulatory Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit signed informed consent must be obtained before any study-specific procedures Exclusion Criteria: Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study. Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment. Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease. Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 162<br>AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42 | Drug: AMG 162<br>* AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42<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 Parent Study 20010223 Baseline to Year 8 |  | 8 years | 
| Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 |  | 8 years | 
| Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 |  | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8 |  | 8 years | 
| Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8 |  | 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone loss, osteoporosis