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

• Status: Withdrawn
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Alendronate; Calcium; Calcium Carbonate; Cholecalciferol; Vitamin D

Criteria

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™)