Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
99 participants
INTERVENTIONAL
2004-10-31
2006-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
DHEA and Yoga
DHEA
50mg daily for 6 months
Yoga
2 sessions per week for 6 months
2
DHEA and exercise
DHEA
50mg daily for 6 months
Aerobics
Walking/chair aerobics program 2 sessions per week for 6 months
3
Placebo and Yoga
Yoga
2 sessions per week for 6 months
Placebo
Placebo supplement every day for 6 months
4
Placebo and exercise
Placebo
Placebo supplement every day for 6 months
Aerobics
Walking/chair aerobics program 2 sessions per week for 6 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DHEA
50mg daily for 6 months
Yoga
2 sessions per week for 6 months
Placebo
Placebo supplement every day for 6 months
Aerobics
Walking/chair aerobics program 2 sessions per week for 6 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
65 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Connecticut
OTHER
National Aeronautics and Space Administration (NASA)
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Connecticut Center on Aging
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne Kenny, MD
Role: PRINCIPAL_INVESTIGATOR
University of Connecticut Center on Aging
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Connecticut Health Center
Farmington, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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. doi: 10.2105/ajph.92.10.1611. No abstract available.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NNG04GK63G
Identifier Type: -
Identifier Source: secondary_id
AG0099
Identifier Type: -
Identifier Source: org_study_id