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

NCT00529659 | Completed Phase 2 Results

• 2 other identifiers: 0773-0052007_532
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Sarcopenia

Keywords

Sarcopenia (loss of muscle mass)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change From Baseline in Participant Short Physical Performance Battery (SPPB)

  Baseline, Month 6

• Change From Baseline in Participant Gait Speed

  Baseline, Month 6

• Change From Baseline in Stair Climbing Power

  Baseline, Month 6

• Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score

  Baseline, Month 6

Study Arms (2)

MK-0773

EXPERIMENTAL

MK-0773

Drug: Comparator: MK-0773

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

Interventions

Comparator: MK-0773 DRUG

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

MK-0773

Comparator: Placebo DRUG

Placebo tablets twice daily, 6 month treatment period

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient has serious neurological, rheumatologic, cardiac, respiratory, kidney, psychiatric conditions
• Patient has a history of certain types of cancer

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 with sarcopenia. J Nutr Health Aging. 2013;17(6):533-43. doi: 10.1007/s12603-013-0335-x.

  PMID: 23732550 RESULT

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 14, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 16, 2015
• Results First Posted: July 2, 2012

Record last verified: 2015-01