Clinical trial NCT00729183: Study to Evaluate Efficacy of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Bone Micro-architecture and Overall Safety in Postmenopausal Women (MK-0822-031)
Official title: A Phase III Randomized, Placebo-Controlled Study to Evaluate the Effect of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety, and to Estimate the Effect of Odanacatib (MK-0822) on Bone Micro-architecture in Postmenopausal Women Treated With Vitamin D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-07
Enrollment: 214
Sex: FEMALE
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: This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine compared to placebo at 12 months.


Eligibility criteria: Inclusion Criteria:

* Participant has been postmenopausal for 3 years
* Participant has BMD t-score at the total hip, hip trochanter, femoral neck, or lumbar spine ≥ -1.5 but \> -3.5
* Participant has 2 hips that are evaluable by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), e.g. contain no hardware from orthopedic procedures
* Participant is ambulatory

Exclusion Criteria:

* Participant has had a previous hip fracture
* Participant has had \>1 prior clinical vertebral fracture AND is a candidate for osteoporosis therapy
* Participant has been treated with oral bisphosphonates, strontium, parathyroid hormone (PTH) or other agents with an effect on bone
* Participant has had metabolic bone disorder other than osteoporosis
* Participant has renal stones, Parkinson's disease, multiple sclerosis (MS) or active parathyroid disease.

Primary outcomes:
measure: Percent Change From Baseline to Month 12 in Lumbar Spine Areal Bone Mineral Density (aBMD)
timeFrame: Baseline, 12 months
measure: Percentage of Participants That Experienced an Adverse Event (AE)
timeFrame: Up to ~14 days post study end (up to ~24 months)
measure: Percentage of Participants That Discontinued Study Treatment Due to an AE
timeFrame: Up to ~14 days post study end (up to ~24 months)
Secondary outcomes:
measure: Percent Change From Baseline to Month 24 in Lumbar Spine aBMD
timeFrame: Baseline, 24 months
measure: Percent Change From Baseline in Total Hip aBMD
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Femoral Neck aBMD
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Hip Trochanter aBMD
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Total Radius aBMD
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Ultradistal Radius aBMD
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Distal Radius aBMD
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Trabecular Volumetric Bone Mineral Density (vBMD) at Central Section of Spine (L1)
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Trabecular vBMD at Central Section of Spine (L2)
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Serum C-Terminal Telopeptides of Type 1 Collagen (s-CTx) Level
timeFrame: Baseline, 12 months, 24 months
measure: Percent Change From Baseline in Serum N-Terminal Propeptides of Type 1 Collagen (s-P1NP) Level
timeFrame: Baseline, 12 months, 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Engelke K, Fuerst T, Dardzinski B, Kornak J, Ather S, Genant HK, de Papp A. Odanacatib treatment affects trabecular and cortical bone in the femur of postmenopausal women: results of a two-year placebo-controlled trial. J Bone Miner Res. 2015 Jan;30(1):30-8. doi: 10.1002/jbmr.2292.
citation: Brixen K, Chapurlat R, Cheung AM, Keaveny TM, Fuerst T, Engelke K, Recker R, Dardzinski B, Verbruggen N, Ather S, Rosenberg E, de Papp AE. Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomized trial. J Clin Endocrinol Metab. 2013 Feb;98(2):571-80. doi: 10.1210/jc.2012-2972. Epub 2013 Jan 21.