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

Phase 3

Withdrawn

• Conditions: Osteoporosis; Postmenopausal Osteoporosis
• Interventions: Drug: Odanacatib; Drug: Alendronate; Dietary Supplement: Cholecalciferol (Vitamin D3); Other: Placebo (odanacatib); Dietary Supplement: Calcium carbonate; Other: Placebo (alendronate)

• Registration Number: NCT01552122
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Study Start: 2012-05
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-26
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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™)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Odanacatib	Calcium carbonate	-
Odanacatib	Odanacatib	-
Odanacatib	Cholecalciferol (Vitamin D3)	-
Odanacatib	Placebo (alendronate)	-
Alendronate	Placebo (odanacatib)	-
Alendronate	Cholecalciferol (Vitamin D3)	-
Alendronate	Calcium carbonate	-
Alendronate	Alendronate	-

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck	Baseline and Month 24

Secondary Outcome Measures

Name	Time	Method
Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter	Baseline and Month 24