Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032)

Summary

The purpose of this study is to demonstrate an improvement in physical functional recovery, following administration of Drug for 24 weeks, in patients who have recently experienced a hip fracture. This study will also evaluate the safety and tolerability of Drug. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Timeline

Start

2005-09

Primary completion

2007-08

Completion

2007-08

Outcome

Mixed primary results

paper Primary outcomes were a rank analysis of change during the study in objective functional performance measurements and insulin-like growth factor-1 (IGF-1) levels in blood. PMID 21067829 ↗

paper Gait speed increased by a 0.7-score difference in the means (95% CI = 0.17-1.28; p = 0.011). PMID 21067829 ↗

paper There was no improvement in MK-0677 treated patients in several other functional performance measures. PMID 21067829 ↗

paper Levels of IGF-1 in treated patients increased by 51.4 ng/ml (95% CI = 34.42-68.44; p < 0.001) compared to placebo. PMID 21067829 ↗

Publications

• Adunsky A, Chandler J, Heyden N, Lutkiewicz J, Scott BB, Berd Y, Liu N, Papanicolaou DA. MK-0677 (ibutamoren mesylate) for the treatment of patients recovering from hip fracture: a multicenter, randomized, placebo-controlled phase IIb study. Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):183-9. doi: 10.1016/j.archger.2010.10.004. Epub 2010 Nov 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibutamoren	Small molecule	25 mg	—

Indications

No indication recorded.