Phase 2
N=170
A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT00529659 ↗Enrolled (actual)
170
Serious AEs
12.4%
Results posted
Jul 2012
Primary outcome: Primary: Change From Baseline in Participant Lean Body Mass — 1.26; 0.29 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Comparator: MK-0773 (Drug); Comparator: Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Participant Lean Body Mass |
1.26; 0.29 | — |
| PRIMARY Change From Baseline in Bilateral Leg Press (BLP) Measurement |
17.42; 15.95 | — |
| SECONDARY Change From Baseline in Participant Short Physical Performance Battery (SPPB) |
0.92; 0.88 | — |
| SECONDARY Change From Baseline in Participant Gait Speed |
6.24; 8.91 | — |
| SECONDARY Change From Baseline in Stair Climbing Power |
19.68; 14.98 | — |
| SECONDARY Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score |
59.79; 59.13; 2.52; 2.38 | — |
Summary
A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00529659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.