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

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

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

Conditions
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Sarcopenia

Intervention / Treatment
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* Drug: Comparator: MK-0773
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0773<br>MK-0773 | Drug: Comparator: MK-0773<br>* MK-0773 50 mg tablets twice daily, 6 month treatment period<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Comparator: Placebo<br>* Placebo tablets twice daily, 6 month treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Participant Lean Body Mass |  | Baseline, Month 6 | 
| 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. | Baseline, Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Month 6 | 
| Change From Baseline in Participant Gait Speed |  | Baseline, Month 6 | 
| 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. | Baseline, Month 6 | 
| 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. | Baseline, Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia (loss of muscle mass)