Clinical trial NCT00620113: Efficacy and Safety of Odanacatib (MK-0822) in Participants With Involutional Osteoporosis (MK-0822-022)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Dose-Finding Study of MK-0822 in the Treatment of Involutional Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis Postmenopausal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 287
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the dose-response on the percent change from baseline in lumbar spine bone mineral density (BMD) at lumbar vertebrae 1 to 4 (L1- L4) when odanacatib (MK-0822) 10 mg, 25 mg, 50 mg or placebo is orally administered once weekly for 52 weeks to Japanese involutional osteoporosis participants. The study will also assess safety and tolerability of odanacatib (10, 25, and 50 mg) in these participants.

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.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman (for at least 5 years) or men who are aged between 45 to 85
* 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 secondary osteoporosis or has a metabolic bone disorder other than osteoporosis or osteopenia
* Participant has received osteoporosis medications or other medications that affect bone
* Participant is already participating in another drug study

Primary outcomes:
measure: Percent Change From Baseline to Week 52 in Lumbar Spine Bone Mineral Density (BMD) at Lumbar Vertebrae 1 to 4 (L1-L4)
timeFrame: Baseline (Observation visit to Wk 0 treatment visit), Week 52
measure: Number of Participants That Experienced an Adverse Event (AE)
timeFrame: From first dose up to Post-Study (up to 54 weeks)
measure: Number of Participants That Discontinued Study Drug Due to an AE
timeFrame: From first dose up to end of treatment (up to 52 weeks)
Secondary outcomes:
measure: Percent Change From Baseline to Week 52 in Total Hip BMD
timeFrame: Baseline (Observation visit to Wk 0 treatment visit), Week 52
measure: Percent Change From Baseline to Week 52 in Femoral Neck BMD
timeFrame: Baseline (Observation visit to Wk 0 treatment visit), Week 52
measure: Percent Change From Baseline to Week 52 in Trochanter BMD
timeFrame: Baseline (Observation visit to Wk 0 treatment visit), Week 52
measure: Percent Change From Baseline to Week 52 in Urinary N-telopeptides/Creatinine (u-NTx/Cre) Ratio
timeFrame: Baseline (Wk 0), Week 52
measure: Percent Change From Baseline to Week 52 in Serum C-Telopeptides of Type 1 Collagen (s-CTx) Level
timeFrame: Baseline (Wk 0), Week 52
measure: Percent Change From Baseline to Week 52 in Urinary Deoxypyridinoline/Creatinine Ratio (u-DPD/Cre)
timeFrame: Baseline (Wk 0), Week 52
measure: Percent Change From Baseline to Week 52 in Serum Bone Specific Alkaline Phosphatase (s-BSAP) Level
timeFrame: Baseline (Wk 0), Week 52
measure: Percent Change From Baseline to Week 52 in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level
timeFrame: Baseline (Wk 0), Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.