BHS4 - Bone/Muscle Changes Following Hip Fracture in Older White Women (Hip4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390741
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : May 29, 2008
National Institute on Aging (NIA)
Information provided by:
University of Maryland

Brief Summary:

The major goals of this study are:

  1. To conduct an intervention development study to evaluate the feasibility of implementing an exercise intervention for reduction losses in bone mineral density, muscle mass, and strength, and clinically relevant aspects of functioning following a hip fracture, and to obtain preliminary tests of the effective ness of these interventions.
  2. To evaluate the effect of home-based exercise intervention on bone metabolism.
  3. To evaluate the effects of hip fracture on bone metabolism.
  4. To evaluate the effects of exercise and hip fracture on hormonal regulators.
  5. To evaluate the association between markers of bone metabolism hormone regulators, and BMD.
  6. To separate out the effects of hip fracture on bone turnover from those of aging in persons with low bone mineral density.

Condition or disease Intervention/treatment
Hip Fracture Behavioral: Exercise Plus Program

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Bone/Muscle Changes Following Hip Fracture in Older White Women
Study Start Date : October 1998
Primary Completion Date : September 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Home-based exercise program
Behavioral: Exercise Plus Program
Those assigned to the treatment group were visited by an exercise trainer three times a week for the first two months of the study, two times per week during months three and four, one time per week during months five and six, two times a month during months seven and eight, and one time a month during months nine through twelve. During months seven through twelve of the study the trainer contacted the participant by telephone once each week during the weeks that he or she did not go the participants' home.
Other Name: Exercise
No Intervention: 2
Usual care

Primary Outcome Measures :
  1. Self-efficacy [ Time Frame: 2, 6, and 12 months post hip fracture ]
  2. Exercise behavior and activity [ Time Frame: 2, 6, and 12 months post hip fracture ]
  3. Subjective reporting of exercise [ Time Frame: 2, 6, and 12 months post hip fracture ]

Secondary Outcome Measures :
  1. Compliance [ Time Frame: 2, 6, and 12 months post hip fracture ]
  2. Change in BMD [ Time Frame: 2, 6, and 12 months post hip fracture ]
  3. Lower extremity function [ Time Frame: 2, 6, and 12 months post hip fracture ]
  4. Falls [ Time Frame: 2, 6, and 12 months post hip fracture ]
  5. Time to weight bearing [ Time Frame: 2, 6, and 12 months post hip fracture ]
  6. Dietary intake [ Time Frame: 2, 6, and 12 months post hip fracture ]

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hip fracture

Exclusion Criteria:

  • Male
  • Under 65 years old
  • Non-surgical repair of hip fracture
  • Non-community dwelling
  • Fractured more than 72 hours before admission to the hospital
  • Pathologic fracture
  • Resides more than 70 miles from the hospital of admission
  • Recent diagnosis (in past 6 months) of angina or myocardial infarction
  • Myocardial infarction or stroke concurrent with hip fracture
  • Diagnosis of ventricular arrhythmia, third degree heart block, atrial fibrillation or if vital signs equal heart less than 60 or greater than 100
  • Active or suspected myocarditis or pericarditis in the past year
  • Recent (within past 6 months) deep venous thrombosis or intracardiac thrombi
  • Persistent pulmonary edema during hospitalization
  • Poorly controlled blood pressure w/ resting systolic greater than 180 mm Hg or resting diastolic greater than 100 mm Hg (3 or more readings with 24- hour period)
  • Presence of ventricular aneurysm
  • Paget's Disease
  • Diabetes--blood sugar consistently greater than 300
  • Diagnosis of thyrotoxicosis or myxedema within past year
  • Any diagnosis of hyperparathyroidism, hypoparathyroidism, or osteomalacia
  • Parkinson's, multiple sclerosis, or ALS (Lou Gehrig's disease)
  • New (past 6 months) onset seizure disorder or seizure within the past 6 months
  • Diagnosis of schizophrenia
  • Recent (within past 6 months) GI hemorrhage or bleeding
  • Preadmission coumadin therapy
  • Cirrhosis or end stage renal disease (ESRD)
  • Advanced hepatitis, AIDS, or endocarditis
  • Cancer with metastases, or cancer under active treatment (chemotherapy with cytotoxic agents) other than non-melanomic skin cancers
  • Current diagnosis of chronic alcohol abuse
  • Preadmission narcotic use or preadmission benzodiazepine use more than 1 dose or tablet a day
  • Required human assistance to walk prior to fracture
  • Prior fracture
  • Chest pains when climbing a flight of stairs, while walking on level ground, or at rest prior to the hip fracture
  • Use of supplemental oxygen prior to fracture
  • Other (Non-English speaking, severe blindness, paraplegia, hemiplegia
  • Mini-Mental Status Exam score less than 20

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390741

United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Northwest Hospital Center
Randallstown, Maryland, United States, 21133
St. Joseph's Hospital
Towson, Maryland, United States, 21204
Sponsors and Collaborators
University of Maryland
National Institute on Aging (NIA)
Principal Investigator: Jay Magaziner, Ph.D., MSHyg University of Maryland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jay Magaziner, PhD, MSHyg/Principal Investigator, University of Maryland School of Medicine Identifier: NCT00390741     History of Changes
Other Study ID Numbers: H-20834
NIA R37 AG09901
First Posted: October 20, 2006    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by University of Maryland:
hip fracture
bone mineral density

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries