Effects of DHEA/Exercise on Bone, Muscle and Balance - Full Text View

Sponsors and Collaborators:	National Aeronautics and Space Administration (NASA) University of Connecticut
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00664053

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Frailty	Dietary Supplement: DHEA Behavioral: Yoga Dietary Supplement: Placebo Behavioral: Aerobics	Phase IV

MedlinePlus related topics: Dietary Supplements Diets Exercise and Physical Fitness Osteoporosis

Drug Information available for: Prasterone Dehydroepiandrosterone sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Factorial Assignment, Efficacy Study
Official Title:	Effects of DHEA/Exercise on Bone, Muscle and Balance

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Muscle strength, bone turnover markers [ Time Frame: baseline, 3 month and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in activities of daily living, cognitive and emotional function [ Time Frame: baseline and 6 months ]
Laboratory tests to measure factors that may reflect or influence changes in bone metabolism [ Time Frame: baseline and 6 months ]

Enrollment:	99
Study Start Date:	October 2004
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DHEA and Yoga	Dietary Supplement: DHEA 50mg daily for 6 months Behavioral: Yoga 2 sessions per week for 6 months
2: Active Comparator DHEA and exercise	Dietary Supplement: DHEA 50mg daily for 6 months Behavioral: Aerobics Walking/chair aerobics program 2 sessions per week for 6 months
3: Active Comparator Placebo and Yoga	Behavioral: Yoga 2 sessions per week for 6 months Dietary Supplement: Placebo Placebo supplement every day for 6 months
4: Placebo Comparator Placebo and exercise	Dietary Supplement: Placebo Placebo supplement every day for 6 months Behavioral: Aerobics Walking/chair aerobics program 2 sessions per week for 6 months

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 or estrogen receptors in bone, muscle or brain. Or the effects may be indirect, countering effects of the stress response.

The specific aims of this study are:

To determine the effects of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on muscle strength, balance, body composition and physical performance measures over 6 months in women with osteopenia and some degree of frailty
To determine the effect of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664053

Locations

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-5215

Sponsors and Collaborators

National Aeronautics and Space Administration (NASA)

University of Connecticut

Investigators

Principal Investigator:

Anne Kenny, MD

University of Connecticut Center on Aging

More Information

Publications:

von Mühlen D, Laughlin GA, Kritz-Silverstein D, Bergstrom J, Bettencourt R. Effect of dehydroepiandrosterone supplementation on bone mineral density, bone markers, and body composition in older adults: the DAWN trial. Osteoporos Int. 2008 May;19(5):699-707. Epub 2007 Dec 15.

Wang YD, Wang L, Li DJ, Wang WJ. Dehydroepiandrosterone inhibited the bone resorption through the upregulation of OPG/RANKL. Cell Mol Immunol. 2006 Feb;3(1):41-5.

Greendale GA, McDivit A, Carpenter A, Seeger L, Huang MH. Yoga for women with hyperkyphosis: results of a pilot study. Am J Public Health. 2002 Oct;92(10):1611-4. No abstract available.

Responsible Party:	University of Connecticut Center on Aging ( Anne Kenny, MD, Associate Professor of Medicine )
Study ID Numbers:	AG0099, NNG04GK63G
Study First Received:	April 18, 2008
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00664053 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

bone mineral density
bone turnover markers
strength
balance

Study placed in the following topic categories:

Immunologic Factors
Musculoskeletal Diseases
Adjuvants, Immunologic
Dehydroepiandrosterone

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Immunologic Factors
Musculoskeletal Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Dehydroepiandrosterone

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009