A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
NCT ID: NCT01120600
Last Updated: 2018-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
294 participants
INTERVENTIONAL
2010-06-09
2013-07-22
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 50 mg once weekly
Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
Odanacatib
One 50 mg tablet once weekly
Vitamin D3
5600 IU of open-label Vitamin D3 once weekly
Calcium carbonate
Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Placebo once weekly
Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg.
Placebo for Odanacatib
One 50 mg tablet once weekly
Vitamin D3
5600 IU of open-label Vitamin D3 once weekly
Calcium carbonate
Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Interventions
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Odanacatib
One 50 mg tablet once weekly
Placebo for Odanacatib
One 50 mg tablet once weekly
Vitamin D3
5600 IU of open-label Vitamin D3 once weekly
Calcium carbonate
Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has osteoporosis
* Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
* Is ambulatory
Exclusion Criteria
* Had previous hip fragility fracture and is a candidate for standard of care therapy
* Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
* Has had more then one previous vertebral fracture
* Has been diagnosed with metabolic bone disorder other than osteoporosis
* Is Vitamin D deficient
* Has a history of renal stones
* Has active parathyroid disease
* Has history of thyroid disease not well controlled by medication
* Is diagnosed with secondary osteoporosis
* Has a daily calcium intake of \<1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg
* Has a history of malignancy ≤5 years prior to signing informed consent
* Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems
40 Years
95 Years
MALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Binkley N, Orwoll E, Chapurlat R, Langdahl BL, Scott BB, Giezek H, Santora AC. Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis. Osteoporos Int. 2021 Jan;32(1):173-184. doi: 10.1007/s00198-020-05701-9. Epub 2020 Nov 17.
Other Identifiers
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2010_532
Identifier Type: OTHER
Identifier Source: secondary_id
0822-053
Identifier Type: -
Identifier Source: org_study_id
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