Effects of DHEA/Exercise on Bone, Muscle and Balance

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoporosis, Frailty

In brief

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 DHEAS supplementation and Hatha yoga. Investigators believe the effects of both treatments will improve outcomes more than either treatment alone and may be additive; in addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical performance will improve following treatment with DHEA and/or yoga.

Key facts

Study ID

NCT00664053

Run by

National Aeronautics and Space Administration (NASA)

People needed

99

Starts

2004-10-01

Expected to finish

2006-10-01

Last updated by the study team

2008-04-29

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

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