Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)

Study Overview
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Brief Summary
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This study will evaluate the therapeutic effects and safety of odanacatib on bone mineral density in osteoporotic postmenopausal women who were previously treated with alendronate.

Official Title
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A Phase III Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density, Tolerability, and Safety in the Treatment of Postmenopausal Women With Osteoporosis Previously Treated With Alendronate

Conditions
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Osteoporosis, Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Odanacatib
* Drug: Alendronate
* Other: Placebo (odanacatib)
* Dietary Supplement: Cholecalciferol (Vitamin D3)
* Dietary Supplement: Calcium carbonate
* Other: Placebo (alendronate)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In good general health, and postmenopausal for at least 5 years or more Diagnosed with postmenopausal osteoporosis Currently taking alendronate for at least 3 years or more for the treatment of osteoporosis One hip free of orthopedic hardware (ie, total hip device, hip pin); anatomy is suitable to undergo a dual-emission X-ray absorptiometry (DXA) scan (ie, bone mineral density scan) Agrees to not to use any other medications for the treatment of osteoporosis except those provided to the participant during the study Exclusion Criteria: Evidence of metabolic bone disorder History of malignancy (cancer) for 5 years or less Active thyroid disease that cannot be managed with medication Severe renal insufficiency (kidney disease), myocardial infarction, unstable angina, stroke or revascularization, untreated malabsorption syndrome, and/or osteonecrosis of the jaw, or anticipates undergoing a major dental procedure (e.g. dental extraction or implantation) Use, misuse, abuse, and/or addiction of illicit drugs and/or recent history (within the last year) of drug or alcohol abuse or dependence Use of estrogen with or without progestin and/or raloxifene (ie, Evista®) or tamoxifen (ie, Nolvadex®, Tamofen®) Use of any oral bisphosphonate therapy other than alendronate; intravenous bisphosphonates (zoledronate, ibandronate, pamidronate); any form of calcitonin other than intranasal; anabolic steroids; and/or Strontium-containing products (ie, Osteovalin™)

Ages Eligible for Study
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Minimum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Odanacatib<br> | Drug: Odanacatib<br>* Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months<br>* Other names: MK-0822;Dietary Supplement: Cholecalciferol (Vitamin D3)<br>* Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.<br>Dietary Supplement: Calcium carbonate<br>* Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.<br>Other: Placebo (alendronate)<br>* One compressed tablet administered orally, once-a-week, for 24 months.<br>|
| Active Comparator: Alendronate<br> | Drug: Alendronate<br>* Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.<br>* Other names: Fosamax;Other: Placebo (odanacatib)<br>* One compressed tablet administered orally, once-a-week, for 24 months.<br>Dietary Supplement: Cholecalciferol (Vitamin D3)<br>* Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.<br>Dietary Supplement: Calcium carbonate<br>* Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck |  | Baseline and Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter |  | Baseline and Month 24 |