OsteoporosisPhase 4NCT00664053
Effects of DHEA/Exercise on Bone, Muscle and Balance
A Phase 4 study testing DHEA, Yoga and Aerobics in people with Osteoporosis and Frailty, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Frailty
- What is being tested?
- DHEA, Yoga and Aerobics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030-5215
About this study
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.
Read the 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.
- Conditions
- Osteoporosis, Frailty
- Being tested
- DHEA, Yoga, Placebo, Aerobics
- Keywords
- bone mineral density, bone turnover markers, strength, balance
- Medical subject headings
- Osteoporosis, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEADietary supplement
Also called Dehydroepiandrosterone
50mg daily for 6 months
YogaBehavioural
2 sessions per week for 6 months
PlaceboDietary supplement
Placebo supplement every day for 6 months
AerobicsBehavioural
Walking/chair aerobics program 2 sessions per week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DHEA and Yoga Receives: Dietary Supplement: DHEA; Behavioral: Yoga |
| 2 | Active comparator | DHEA and exercise Receives: Dietary Supplement: DHEA; Behavioral: Aerobics |
| 3 | Active comparator | Placebo and Yoga Receives: Behavioral: Yoga; Dietary Supplement: Placebo |
| 4 | Placebo comparator | Placebo and exercise Receives: Dietary Supplement: Placebo; Behavioral: Aerobics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength, bone turnover markers
Measured: baseline, 3 month and 6 months
Secondary outcomes (2)
Changes in activities of daily living, cognitive and emotional function
Measured: baseline and 6 months
Laboratory tests to measure factors that may reflect or influence changes in bone metabolism
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startOct 2004
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Aeronautics and Space Administration (NASA)
- Sponsor type
- US federal agency
- Collaborators
- University of Connecticut
- Investigators
- Anne Kenny, MD, Principal investigator, University of Connecticut Center on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664053
- Sponsor's protocol ID
- AG0099
- Other IDs
- NNG04GK63G
- Status last verified
- Apr 2008
- First submitted
- 18 Apr 2008
- Last updated
- 29 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18084691Wang 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.
PubMed 16549048Greendale 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.
PubMed 12356608Kenny 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.
PubMed 20863330
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of DHEA/Exercise on Bone, Muscle and Balance
- ClinicalTrials.gov ID
- NCT00664053
- Acronym / sponsor ID
- AG0099
- Conditions
- Osteoporosis, Frailty
- Keywords
- bone mineral density, bone turnover markers, strength, balance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- National Aeronautics and Space Administration (NASA)US federal agency
- Collaborators
- University of Connecticut
- Study start
- Oct 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: DHEA, Behavioral: YogaDHEA and Yoga |
| 2 | Active comparator | Dietary Supplement: DHEA, Behavioral: AerobicsDHEA and exercise |
| 3 | Active comparator | Behavioral: Yoga, Dietary Supplement: PlaceboPlacebo and Yoga |
| 4 | Placebo comparator | Dietary Supplement: Placebo, Behavioral: AerobicsPlacebo and exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHEAAlso: Dehydroepiandrosterone50mg daily for 6 months | Dietary supplement | 1, 2 |
| Yoga2 sessions per week for 6 months | Behavioural | 1, 3 |
| PlaceboPlacebo supplement every day for 6 months | Dietary supplement | 3, 4 |
| AerobicsWalking/chair aerobics program 2 sessions per week for 6 months | Behavioural | 2, 4 |
Primary outcome
Muscle strength, bone turnover markers
Time frame: baseline, 3 month and 6 months
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2008.
- Background: PubMed 18084691von 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.
- Background: PubMed 16549048Wang 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.
- Background: PubMed 12356608Greendale 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.
- Derived from this study: PubMed 20863330Kenny 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Kenny, MD principal investigator
University of Connecticut Center on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DHEA, Yoga and Aerobics in people with Osteoporosis and Frailty, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength, bone turnover markers (time frame: baseline, 3 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664053, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2008.