Clinical trial NCT01120600: A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053)
Official title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) in the Treatment of Men With Osteoporosis Treated With Vitamin D and Calcium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 294
Sex: MALE
Minimum age (years): 40
Maximum age (years): 95
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 test the hypothesis that treatment with odanacatib will result in increased bone mineral density (BMD) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis participants.

Detailed description: The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and participants will then remain in the study for an additional 12 months (Part 2). Amendment 1 of the protocol removed the additional 12 month period and the Month 36 BMD analysis was deleted.

Eligibility criteria: Inclusion Criteria:

* Is a male between 40 and 95 years of age
* Has osteoporosis
* Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
* Is ambulatory

Exclusion Criteria:

* Is currently on oral bisphosphonates or other treatment for osteoporosis
* 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

Primary outcomes:
measure: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
timeFrame: Baseline and Month 24
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 24 months (plus 14 days) after first dose of study drug
measure: Number of Participants Who Discontinued Treatment Due to an AE
timeFrame: Up to 24 months after first dose of study drug
Secondary outcomes:
measure: Percentage Change From Baseline in Total Hip BMD at Month 24
timeFrame: Baseline and Month 24
measure: Percentage Change From Baseline in Femoral Neck BMD at Month 24
timeFrame: Baseline and Month 24
measure: Percentage Change From Baseline in Trochanter BMD at Month 24
timeFrame: Baseline and Month 24
measure: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
timeFrame: Baseline and Month 24
measure: Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
timeFrame: Baseline and Month 24
measure: Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
timeFrame: Baseline and Month 24
measure: Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
timeFrame: Baseline and Month 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.