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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients With Sarcopenia

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

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Change From Baseline in Participant Lean Body Mass [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Bilateral Leg Press (BLP) Measurement [ Time Frame: Baseline, Month 6 ]
    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.


Original Primary Outcome:

Current Secondary Outcome:

  • Change From Baseline in Participant Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, Month 6 ]
    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 [ Time Frame: Baseline, Month 6 ]
  • Change From Baseline in Stair Climbing Power [ Time Frame: Baseline, Month 6 ]
    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 [ Time Frame: Baseline, Month 6 ]
    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.


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: September 11, 2007
Date Started: October 2007
Date Completion:
Last Updated: January 29, 2015
Last Verified: January 2015