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

What Was Tested

The trial (phase 2) is built around MK-677 (Ibutamoren).

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 83 actual participants took part.

It was open to people of any sex aged from 60 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patient has had surgery for a unilateral hip fracture, and is considered to be partially or fully weight bearing after the surgery. Surgical repair of the fracture has occurred no more than 4 days post hip fracture. Prior to starting the study medication, the patient is enrolled in a rehabilitation program (as an in-patient or as an out-patient).

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: patient has an unstable medical condition; patient has type i diabetes; patient has type ii diabetes with any of conditions;.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got MK-677 (Ibutamoren) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on MK-677 (Ibutamoren), so expectations could not easily colour the readings.

It started in 2005-09 with completion listed for 2007-08.

It ran at 5 sites in Germany (1), Norway (1), Spain (1), Sweden (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proprietary Information - Exploratory (Non-Confirmatory) Trial.

It also tracked 1 secondary outcome, for example Proprietary Information - Exploratory (Non-Confirmatory) Trial.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of MK-677 (Ibutamoren) in 83 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the MK-677 (Ibutamoren) compound page, all human trials.