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Status: Withdrawn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.
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.
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
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Female.
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™)
Locations and Contacts
Additional Information
Starting date: May 2012
Last updated: August 6, 2014
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