Clinical trial NCT00664053: Effects of DHEA/Exercise on Bone, Muscle and Balance
Official title: Effects of DHEA/Exercise on Bone, Muscle and Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Frailty
Keywords: bone mineral density
bone turnover markers
strength
balance
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: University of Connecticut
First posted: 2008-04-22
Enrollment: 99
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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.

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:

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.

Eligibility 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

Primary outcomes:
measure: Muscle strength, bone turnover markers
timeFrame: baseline, 3 month and 6 months
Secondary outcomes:
measure: Changes in activities of daily living, cognitive and emotional function
timeFrame: baseline and 6 months
measure: Laboratory tests to measure factors that may reflect or influence changes in bone metabolism
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: University of Connecticut Center on Aging
name: Anne Kenny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Muhlen 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. doi: 10.1007/s00198-007-0520-z. Epub 2007 Dec 15.
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.
citation: 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. doi: 10.2105/ajph.92.10.1611. No abstract available.
citation: Kenny AM, Boxer RS, Kleppinger A, Brindisi J, Feinn R, Burleson JA. Dehydroepiandrosterone combined with exercise improves muscle strength and physical function in frail older women. J Am Geriatr Soc. 2010 Sep;58(9):1707-14. doi: 10.1111/j.1532-5415.2010.03019.x.