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Trial · Interventional

TerminatedPhase 2Registry data

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

NCTNCT00128115 (opens ClinicalTrials.gov in a new tab)Other id0677-032Other id2005_028

Overview

Status
Terminated
Phase
Phase 2
Enrollment
83 participants (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Double masking
Countries
5 countries

Germany, Norway, Spain, Sweden, United Kingdom

Start
Sept 2005
Primary completion
Aug 2007
Completion
Aug 2007
First posted
9 Aug 2005 (estimated)
Last update posted
20 Jan 2016 (estimated)
Conditions
Hip Fracture

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008
  1. Ph 2

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

    NCT00128115

    Sept 2005 to Aug 2007

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • MK0677Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary outcomes(1)
  1. Proprietary Information - Exploratory (Non-Confirmatory) Trial

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2011

7 results

MK-0677 (ibutamoren mesylate) for the treatment of patients recovering from hip fracture: a multicenter, randomized, placebo-controlled phase IIb study.

Adunsky et al. 2011Archives of gerontology and geriatricscited by 48

PMID 21067829DOI 10.1016/j.archger.2010.10.004PUB-21067829

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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) * Patient is judged to have been able to ambulate independently at home prior to their hip fracture (able to walk indoors in a familiar setting with little or no aid from another person) Exclusion Criteria: * Patient has an unstable medical condition * Patient has a hip fracture that is due to bone pathology other than osteoporosis (e.g., malignancy, or Paget's Disease), or major trauma (e.g. motor vehicle accident). * Patient has Type I diabetes * Patient has Type II diabetes with any of conditions; 1. Patient is currently taking more than one anti-hyperglycemic agent, or is taking a single combination anti-hyperglycemic drug containing more than one anti-hyperglycemic medication 2. Patient is currently receiving insulin. Note: A short-term course of insulin required for glycemic control post hip fracture surgery is not exclusionary 3. Patient has diabetic retinopathy 4. Patient is unwilling or unable to monitor glucose at home * Patient has been diagnosed with any neuromuscular or neurological disease causing muscle weakness * Patient has cancer, or had a diagnosis of any malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or adequately treated in situ cervical cancer * Patient has active carpal tunnel syndrome * Patient was living in a nursing home prior to the hip fracture (Note: - Patients who were living in an assisted-living facility prior to the hip fracture are eligible for enrollment) * Patient was permanently wheelchair bound prior to the hip fracture

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