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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529659
• Other study ID #: 0773-005
• Secondary ID: 2007_532
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2007
• Last updated: January 29, 2015
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• Comparator: MK-0773
MK-0773 50 mg tablets twice daily, 6 month treatment period
• Comparator: Placebo
Placebo tablets twice daily, 6 month treatment period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 wi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Participant Lean Body Mass		Baseline, Month 6	No
Primary	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	No
Secondary	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	No
Secondary	Change From Baseline in Participant Gait Speed		Baseline, Month 6	No
Secondary	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	No
Secondary	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	No