A Study to Assess Safety and Efficacy of Odanacatib (MK-0822) in Men With Osteoporosis (MK-0822-053 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01120600
First received: May 7, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to test the hypothesis that treatment with odanacatib will result in increased BMD (bone mineral density) compared to treatment with placebo. This study will also evaluate the safety and efficacy of odanacatib for male osteoporosis patients.


Condition Intervention Phase
Osteoporosis
Drug: Odanacatib
Drug: Placebo for Odanacatib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent change from baseline in lumbar spine bone mineral density (BMD) [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline in total hip, femoral neck, and trochanter BMD [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
  • Log-transformed fraction of baseline serum C-Telopeptides of Type 1 collagen (s-CTx) and urine N-Telopeptides of Type 1 collagen (u-NTx) [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]

Enrollment: 294
Study Start Date: July 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Odanacatib
In addition to study drug, all participants will receive a weekly dose 5600 IU of open-label Vitamin D3. Participants will also receive 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.
Drug: Odanacatib
One 50 mg tablet once weekly
Other Name: MK0822
Placebo Comparator: Placebo
In addition to study drug, all participants will receive a weekly dose 5600 IU of open-label Vitamin D3. Participants will also receive 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.
Drug: Placebo for Odanacatib
One 50 mg tablet once weekly

Detailed Description:

The original study was divided into two parts, with the primary analysis of endpoints to occur at 24 months and the patients 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

Ages Eligible for Study:   40 Years to 95 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01120600     History of Changes
Other Study ID Numbers: 0822-053, 2010_532
Study First Received: May 7, 2010
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014