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Completed

NCT Number: NCT00529659

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

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

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: MK-0773

Drug

MK-0773 50 mg tablets twice daily, 6 month treatment period

Comparator: placebo

Drug

Placebo tablets twice daily, 6 month treatment period

Primary outcomes

  1. Change From Baseline in Participant Lean Body Mass

    Time frame: Baseline, Month 6

  2. 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.

Secondary outcomes

  1. 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.

  2. Change From Baseline in Participant Gait Speed

    Time frame: Baseline, Month 6

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 14, 2007
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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