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

January 19, 2016 updated by: Merck Sharp & Dohme LLC

Proprietary Information - Exploratory (Non-Confirmatory) Trial

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Haar, Germany, 85540
        • MSD Sharp & Dohme GmbH
  • Norway
      • Drammen, Norway, 3011
        • MSD (Norge) AS
  • Spain
      • Madrid, Spain, 28027
        • Merck Sharp & Dohme De Espana, S.A.E.
  • Sweden
      • Sollentuna, Sweden, 192 07
        • Merck Sharp & Dohme (Sweden) AB
  • United Kingdom
    • Hertfordshire
      • Hoddesdon, Hertfordshire, United Kingdom, EN11 9BU
        • Merch Sharp & Dohme Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures

Outcome Measure
Proprietary Information - Exploratory (Non-Confirmatory) Trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 5, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 9, 2005

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0677-032
  • 2005_028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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