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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis; Postmenopausal Osteoporosis

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

Phase: Phase 3

Status: Withdrawn

Sponsored by: Merck Sharp & Dohme Corp.


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck

Secondary outcome: Percent Change from Baseline in BMD of the Lumbar Spine, Total Hip, and Trochanter


Minimum age: 60 Years. Maximum age: N/A. Gender(s): Female.


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


- 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™)

Locations and Contacts

Additional Information

Starting date: May 2012
Last updated: August 6, 2014

Page last updated: August 20, 2015

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