Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)
NCT ID: NCT01552122
Last Updated: 2015-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-05-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Odanacatib
Odanacatib
Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months
Cholecalciferol (Vitamin D3)
Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
Calcium carbonate
Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.
Placebo (alendronate)
One compressed tablet administered orally, once-a-week, for 24 months.
Alendronate
Alendronate
Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.
Placebo (odanacatib)
One compressed tablet administered orally, once-a-week, for 24 months.
Cholecalciferol (Vitamin D3)
Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
Calcium carbonate
Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.
Interventions
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Odanacatib
Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months
Alendronate
Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.
Placebo (odanacatib)
One compressed tablet administered orally, once-a-week, for 24 months.
Cholecalciferol (Vitamin D3)
Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
Calcium carbonate
Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.
Placebo (alendronate)
One compressed tablet administered orally, once-a-week, for 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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™)
60 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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0822-050
Identifier Type: -
Identifier Source: org_study_id
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