NCT00128115

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
5 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

August 5, 2005

Last Update Submit

January 19, 2016

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcomes (1)

  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Interventions

MK0677DRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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;
  • 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
  • Patient has diabetic retinopathy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Msd Sharp & Dohme Gmbh

Haar, 85540, Germany

Location

MSD (Norge) AS

Drammen, 3011, Norway

Location

Merck Sharp & Dohme De Espana, S.A.E.

Madrid, Madrid, 28027, Spain

Location

Merck Sharp & Dohme (Sweden) AB

Sollentuna, 192 07, Sweden

Location

Merch Sharp & Dohme Ltd.

Hoddesdon, Hertfordshire, EN11 9BU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21067829DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

ibutamoren mesylate

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 9, 2005

Study Start

September 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

DE(1)ES(1)NO(1)SE(1)GB(1)