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A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: MK-0773
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia (loss of muscle mass)

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is a woman who is 65 years of age or older
  • Patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population
  • Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or Activity Measure for Post Acute Care (AM-PAC)<66

Exclusion Criteria:

  • Patient has serious neurological, rheumatologic, cardiac, respiratory, kidney, psychiatric conditions
  • Patient has a history of certain types of cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MK-0773

    Placebo

    Arm Description

    MK-0773

    Placebo

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Participant Lean Body Mass
    Change From Baseline in Bilateral Leg Press (BLP) Measurement
    BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.

    Secondary Outcome Measures

    Change From Baseline in Participant Short Physical Performance Battery (SPPB)
    The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.
    Change From Baseline in Participant Gait Speed
    Change From Baseline in Stair Climbing Power
    Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says "go" and ends when both of the patient's feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time.
    Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score
    The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.

    Full Information

    First Posted
    September 11, 2007
    Last Updated
    January 29, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00529659
    Brief Title
    A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
    Official Title
    A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients With Sarcopenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    October 2009 (Actual)
    Study Completion Date
    October 2009 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sarcopenia
    Keywords
    Sarcopenia (loss of muscle mass)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    170 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-0773
    Arm Type
    Experimental
    Arm Description
    MK-0773
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: MK-0773
    Intervention Description
    MK-0773 50 mg tablets twice daily, 6 month treatment period
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo tablets twice daily, 6 month treatment period
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Participant Lean Body Mass
    Time Frame
    Baseline, Month 6
    Title
    Change From Baseline in Bilateral Leg Press (BLP) Measurement
    Description
    BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.
    Time Frame
    Baseline, Month 6
    Secondary Outcome Measure Information:
    Title
    Change From Baseline in Participant Short Physical Performance Battery (SPPB)
    Description
    The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons. The SPPB consists of 3 types of physical maneuvers: balance test, speed gait test, and chair stand test. Results from each maneuvers test are scored on a scale of 0 to 4, with an increasing composite score indicating an improved function level. The total maximum score of SPPB is 12.
    Time Frame
    Baseline, Month 6
    Title
    Change From Baseline in Participant Gait Speed
    Time Frame
    Baseline, Month 6
    Title
    Change From Baseline in Stair Climbing Power
    Description
    Stair-climbing power is an alternate measure of lower extremity muscle strength. Participants were asked to climb a standardized 4-step flight of stairs. The study coordinator timed how long it took the participant to walk up the stairs as quickly as possible. The test starts when the tester says "go" and ends when both of the patient's feet are flat on the platform area at the top of the staircase. Participants were permitted to use the railing, and/or an assistive device, if needed. Stair climbing power was calculated as = participant weight × gravity constant × height of stairs / time.
    Time Frame
    Baseline, Month 6
    Title
    Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score
    Description
    The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities, and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.
    Time Frame
    Baseline, Month 6

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is a woman who is 65 years of age or older Patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or Activity Measure for Post Acute Care (AM-PAC)<66 Exclusion Criteria: Patient has serious neurological, rheumatologic, cardiac, respiratory, kidney, psychiatric conditions Patient has a history of certain types of cancer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23732550
    Citation
    Papanicolaou DA, Ather SN, Zhu H, Zhou Y, Lutkiewicz J, Scott BB, Chandler J. A phase IIA randomized, placebo-controlled clinical trial to study the efficacy and safety of the selective androgen receptor modulator (SARM), MK-0773 in female participants with sarcopenia. J Nutr Health Aging. 2013;17(6):533-43. doi: 10.1007/s12603-013-0335-x.
    Results Reference
    result

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    A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)

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