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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120600
First Posted: May 11, 2010
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Osteoporosis Drug: Odanacatib Drug: Placebo for Odanacatib Dietary Supplement: Vitamin D3 Dietary Supplement: Calcium carbonate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:
  • Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24 [ Time Frame: Baseline and Month 24 ]
    Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.

  • Number of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to 24 months (plus 14 days) after first dose of study drug ]
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.

  • Number of Participants Who Discontinued Treatment Due to an AE [ Time Frame: Up to 24 months after first dose of study drug ]
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.


Secondary Outcome Measures:
  • Percentage Change From Baseline in Total Hip BMD at Month 24 [ Time Frame: Baseline and Month 24 ]
    Total hip BMD was assessed by DXA at Baseline and at Month 24.

  • Percentage Change From Baseline in Femoral Neck BMD at Month 24 [ Time Frame: Baseline and Month 24 ]
    Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.

  • Percentage Change From Baseline in Trochanter BMD at Month 24 [ Time Frame: Baseline and Month 24 ]
    Trochanter BMD was assessed by DXA at Baseline and at Month 24.

  • Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24 [ Time Frame: Baseline and Month 24 ]
    Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.

  • Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24 [ Time Frame: Baseline and Month 24 ]
    Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.

  • Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24 [ Time Frame: Baseline and Month 24 ]
    Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.

  • Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24 [ Time Frame: Baseline and Month 24 ]
    Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.


Enrollment: 294
Actual Study Start Date: June 9, 2010
Study Completion Date: July 22, 2013
Primary Completion Date: July 22, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Odanacatib 50 mg once weekly
Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as 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: MK-0822
Dietary Supplement: Vitamin D3
5600 IU of open-label Vitamin D3 once weekly
Dietary Supplement: Calcium carbonate
Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
Placebo Comparator: Placebo once weekly
Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as 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
Dietary Supplement: Vitamin D3
5600 IU of open-label Vitamin D3 once weekly
Dietary Supplement: Calcium carbonate
Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120600


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01120600     History of Changes
Other Study ID Numbers: 0822-053
2010_532 ( Other Identifier: Merck )
First Submitted: May 7, 2010
First Posted: May 11, 2010
Results First Submitted: November 8, 2017
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents