Study of Transitioning From Alendronate to Denosumab

Study Overview
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Brief Summary
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The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Official Title
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A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: alendronate
* Drug: Denosumab (AMG 162)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal females 55 yrs or older Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4 Exclusion Criteria: Vitamin D deficiency Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening

Ages Eligible for Study
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Minimum Age: 55 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 |
| --- | --- |
| Experimental: denosumab<br> | Drug: Denosumab (AMG 162)<br>* 60 mg SC q 6 mos<br>|
| Active Comparator: alendronate<br> | Drug: alendronate<br>* 70 mg oral QW<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Total Hip Bone Mineral Density | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100. | Baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100. | Baseline, 12 months | 
| Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I) | Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100. | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, clinical trial, postmenopausal osteoporosis, alendronate, total hip bone mineral density