Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)
NCT ID: NCT00620113
Last Updated: 2018-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
287 participants
INTERVENTIONAL
2007-12-03
2009-05-29
Brief Summary
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The study will enroll approximately 280 participants and randomly assign them to 3 different doses of odanacatib or placebo for 52 weeks, along with supplemental vitamin D3 and calcium carbonate. The primary efficacy hypothesis is that a dose-response relationship on the percent change from baseline in lumbar spine BMD (L1- L4) is seen when odanacatib 10, 25, 50 mg or placebo is orally administered once weekly for 52 weeks to involutional osteoporosis participants. The primary safety hypothesis is that odanacatib will be safe and well tolerated over 52 weeks to involutional osteoporosis participants.
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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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Placebo
After an observation period of \~5 weeks, participants receive dose-matched placebo to odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 International Units (IU) vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
Placebo
Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.
Odanacatib 10 mg
After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
Odanacatib
Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
Odanacatib 25 mg
After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
Odanacatib
Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
Odanacatib 50 mg
After an observation period of \~5 weeks, participants receive 50 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods.
Odanacatib
Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
Interventions
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Odanacatib
Odanacatib tablets 10 mg, 25 mg, or 50 mg (depending upon randomization), taken orally once weekly for 52 weeks.
Vitamin D3
Two Vitamin D3 tablets (5600 IU total) taken orally once weekly for 52 weeks.
Calcium carbonate
Calcium carbonate 500 mg tablet taken orally every day for 52 weeks.
Placebo
Dose-matched placebo tablets to odanacatib, taken orally once weekly for 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant who has low bone mineral density
* Participant has anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumber spine and hip
* Participant is ambulatory (can walk)
Exclusion Criteria
* Participant has received osteoporosis medications or other medications that affect bone
* Participant is already participating in another drug study
45 Years
85 Years
ALL
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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Nakamura T, Shiraki M, Fukunaga M, Tomomitsu T, Santora AC, Tsai R, Fujimoto G, Nakagomi M, Tsubouchi H, Rosenberg E, Uchida S. Effect of the cathepsin K inhibitor odanacatib administered once weekly on bone mineral density in Japanese patients with osteoporosis--a double-blind, randomized, dose-finding study. Osteoporos Int. 2014 Jan;25(1):367-76. doi: 10.1007/s00198-013-2398-2. Epub 2013 May 29.
Other Identifiers
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MK-0822-022
Identifier Type: OTHER
Identifier Source: secondary_id
2007_034
Identifier Type: OTHER
Identifier Source: secondary_id
0822-022
Identifier Type: -
Identifier Source: org_study_id
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