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

Merck Sharp & Dohme LLC0 sitesMay 2012

ConditionsOsteoporosis Postmenopausal Osteoporosis

InterventionsPlacebo (alendronate)Odanacatib Cholecalciferol (Vitamin D3)Calcium carbonate Alendronate Placebo (odanacatib)

DrugsOdanacatib Alendronate

Overview

Phase: Phase 3
Intervention: Placebo (alendronate)
Conditions: Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Primary Endpoint: Percent Change from Baseline in Bone Mineral Density (BMD) of the Femoral Neck
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

February 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility 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™)