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

• ClinicalTrials.gov Identifier: NCT00529659
• Recruitment Status: Completed
• First Posted: September 14, 2007
• Results First Posted: July 2, 2012
• Last Update Posted: February 16, 2015
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sarcopenia	Drug: Comparator: MK-0773; Drug: Comparator: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients With Sarcopenia
• Study Start Date: October 2007
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: October 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: MK-0773; MK-0773	Drug: Comparator: MK-0773; MK-0773 50 mg tablets twice daily, 6 month treatment period
Placebo Comparator: Placebo; Placebo	Drug: Comparator: Placebo; Placebo tablets twice daily, 6 month treatment period

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

Publications of Results:

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.

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00529659
• Other Study ID Numbers: 0773-005; 2007_532
• First Posted: September 14, 2007
• Results First Posted: July 2, 2012
• Last Update Posted: February 16, 2015
• Last Verified: January 2015

Keywords provided by Merck Sharp & Dohme Corp.:

Sarcopenia (loss of muscle mass)

Additional relevant MeSH terms:

Sarcopenia; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical