Status:
COMPLETED
Effects of DHEA/Exercise on Bone, Muscle and Balance
Lead Sponsor:
National Aeronautics and Space Administration (NASA)
Collaborating Sponsors:
University of Connecticut
Conditions:
Osteoporosis
Frailty
Eligibility:
FEMALE
65+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine whether muscle strength and balance will improve in women with frailty selected for dehydroepiandrosterone sulfate (DHEAS) levels below 550 ng/dl treated with D...
Detailed Description
Dehydroepiandrosterone (DHEAS) and yoga may mitigate or reverse the effects of aging and frailty on bone, muscle and balance loss. The mechanism of the effects may be direct - working through androgen...
Eligibility Criteria
Inclusion
- Women over age 65 years
- Bone mineral density t-score less than -1
- At least one of the five components of the frailty phenotype (low hand grip strength, low walking speed, low physical activity, weight loss or sense of exhaustion)
- DHEAS levels less than 550 ng/dl
- Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
- Mammogram within the preceding 12 months
Exclusion
- Disease or medication known to affect bone or muscle metabolism (i.e., Paget's disease, osteomalacia or 25OHD level less than 10 ng/dl, hyperparathyroidism: current use of corticosteroids, calcitonin, heparin, phenytoin, phenobarbital, methotrexate, bisphosphonates, calcitonin, selective estrogen receptor modulator or PTH)
- Use of androgen or estrogen in the preceding year
- Use of psychiatric medications including antipsychotic medications and SSRI
- Metastatic or advanced cancer (other than skin cancer)
- History of breast cancer
- Active cardiac ischemia by history of angina or myocardial infarction in the preceding 6 months
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00664053
Start Date
October 1 2004
End Date
October 1 2006
Last Update
April 29 2008
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-5215