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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Odanacatib
Placebo for Odanacatib
Vitamin D3
Calcium carbonate
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Odanacatib 50 mg once weekly

    Placebo once weekly

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 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)
    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
    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
    Total hip BMD was assessed by DXA at Baseline and at Month 24.
    Percentage Change From Baseline in Femoral Neck BMD at 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
    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
    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
    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
    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
    Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.

    Full Information

    First Posted
    May 7, 2010
    Last Updated
    July 30, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01120600
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 9, 2010 (Actual)
    Primary Completion Date
    July 22, 2013 (Actual)
    Study Completion Date
    July 22, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    294 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Odanacatib 50 mg once weekly
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo once weekly
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Odanacatib
    Other Intervention Name(s)
    MK-0822
    Intervention Description
    One 50 mg tablet once weekly
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for Odanacatib
    Intervention Description
    One 50 mg tablet once weekly
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D3
    Intervention Description
    5600 IU of open-label Vitamin D3 once weekly
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Calcium carbonate
    Intervention Description
    Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
    Primary Outcome Measure Information:
    Title
    Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24
    Description
    Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
    Time Frame
    Baseline and Month 24
    Title
    Number of Participants Who Experienced an Adverse Event (AE)
    Description
    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.
    Time Frame
    Up to 24 months (plus 14 days) after first dose of study drug
    Title
    Number of Participants Who Discontinued Treatment Due to an AE
    Description
    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.
    Time Frame
    Up to 24 months after first dose of study drug
    Secondary Outcome Measure Information:
    Title
    Percentage Change From Baseline in Total Hip BMD at Month 24
    Description
    Total hip BMD was assessed by DXA at Baseline and at Month 24.
    Time Frame
    Baseline and Month 24
    Title
    Percentage Change From Baseline in Femoral Neck BMD at Month 24
    Description
    Femoral Neck BMD was assessed by DXA at Baseline and at Month 24.
    Time Frame
    Baseline and Month 24
    Title
    Percentage Change From Baseline in Trochanter BMD at Month 24
    Description
    Trochanter BMD was assessed by DXA at Baseline and at Month 24.
    Time Frame
    Baseline and Month 24
    Title
    Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
    Description
    Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Month 24.
    Time Frame
    Baseline and Month 24
    Title
    Percentage Change From Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
    Description
    Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Month 24.
    Time Frame
    Baseline and Month 24
    Title
    Percentage Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
    Description
    Serum samples were collected to evaluate biochemical markers for s-BSAP, which were measured at Baseline and at Month 24.
    Time Frame
    Baseline and Month 24
    Title
    Percentage Change From Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
    Description
    Serum samples were collected to evaluate biochemical markers for s-P1NP, which were measured at Baseline and at Month 24.
    Time Frame
    Baseline and Month 24

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    33200257
    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.
    Results Reference
    derived

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

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