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

Merck Sharp & Dohme (MSD)

Status and phase: Withdrawn; Phase 3

Conditions: Postmenopausal Osteoporosis; Osteoporosis

Treatments: Dietary Supplement: Cholecalciferol (Vitamin D3); Dietary Supplement: Calcium carbonate; Other: Placebo (alendronate); Drug: Alendronate; Other: Placebo (odanacatib); Drug: Odanacatib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01552122

0822-050

Details and patient eligibility

About

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.

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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™)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Odanacatib

Experimental group

Treatment:

Dietary Supplement: Cholecalciferol (Vitamin D3)

Drug: Odanacatib

Dietary Supplement: Calcium carbonate

Other: Placebo (alendronate)

Alendronate

Active Comparator group

Treatment:

Other: Placebo (odanacatib)

Dietary Supplement: Cholecalciferol (Vitamin D3)

Dietary Supplement: Calcium carbonate

Drug: Alendronate