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

Phase 2CompletedNCT00529659

Merck Sharp & Dohme LLC170 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

170

Conditions

Sarcopenia

Interventions

Comparator: MK-0773DRUG

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

Comparator: PlaceboDRUG

Placebo tablets twice daily, 6 month treatment period

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in Participant Lean Body Mass

Time frame: 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.

Time frame: Baseline, Month 6

Secondary Outcomes

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.

Time frame: Baseline, Month 6

Change From Baseline in Participant Gait Speed

Time frame: 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.

Data from ClinicalTrials.gov

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