Effects of DHEA/Exercise on Bone, Muscle and Balance

Osteoporosis Clinical Trial

Official title:

Effects of DHEA/Exercise on Bone, Muscle and Balance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00664053
• Other study ID #: AG0099
• Secondary ID: NNG04GK63G
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2008
• Last updated: April 25, 2008
• Start date: October 2004
• Est. completion date: October 2006

Study information

• Verified date: April 2008
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 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.

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:

1. 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

2. To determine the effect of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Frailty
• Osteoporosis

Intervention

Dietary Supplement:
• DHEA
50mg daily for 6 months

Behavioral:
• Yoga
2 sessions per week for 6 months

Dietary Supplement:
• Placebo
Placebo supplement every day for 6 months

Behavioral:
• Aerobics
Walking/chair aerobics program 2 sessions per week for 6 months

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
National Aeronautics and Space Administration (NASA)	University of Connecticut

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength, bone turnover markers		baseline, 3 month and 6 months	No
Secondary	Changes in activities of daily living, cognitive and emotional function		baseline and 6 months
Secondary	Laboratory tests to measure factors that may reflect or influence changes in bone metabolism		baseline and 6 months