Effects of DHEA and Exercise on Bone Marrow Fat in Postmenopausal Women (NCT05316272) | Clinical Trial Compass
CompletedNot Applicable
Effects of DHEA and Exercise on Bone Marrow Fat in Postmenopausal Women
United States41 participantsStarted 2022-03-11
Plain-language summary
Bone strength -the main determinant of bone fracture- is a function not only of bone mineral density (BMD) and microstructure, but also of its microenvironment, including bone marrow fat (BMF). The adrenal steroid dehydroepiandrosterone (DHEA) -the main precursor for estrogens and androgens in postmenopausal women- as well as bone-loading exercise, increase BMD in older women, however, their effects on BMF are largely unknown. This study has high potential to unveil the hormonal and mechanical effects of DHEA and exercise on BMF, respectively, and to elucidate longitudinal associations of BMF with bone strength in older women with bone loss.
Who can participate
Age range
55 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* women aged 55 to 85 years
* non-frail, as determined by Short Physical Performance Battery score \> 9 (0-12 scale)
* 5 years or longer since menopause (defined as last menstrual period)
* willing to participate in a 36-week exercise program that will start at a moderate intensity and gradually progress to a higher intensity
* willing to take DHEA (50mg/d) or a placebo pill daily and remain blinded for up to 36 weeks
* not performing resistance exercise training or high impact weight-bearing exercise (e.g., jogging) ≥ 2 days per week in the past 6 months
* ambulatory without assistive devices
* serum DHEAS \< 140 μg/dL (3.8 μmol/L)
* low bone mass or moderate osteoporosis indicated by lumbar spine, total hip, or femoral neck aBMD t-scores \< -1.0 and ≥ -3.0
* refusal of standard osteoporosis treatment in women with moderate osteoporosis (BMD ≥-3.0 and ≤ -2.5)
* evidence of a negative (no findings suspicious for breast cancer) mammogram within the past 12 months
* planning to reside in the Denver area for the duration of the study
* willing to provide evidence of completed COVID-19 vaccination
* no implanted metal or electronic devices
* no metallic foreign body in the eye
* no "triggerfish" contact lenses
* no gastric reflux device
* no insulin pumps
* no temporary transvenous pacing leads
* no aneurysm clips
* no cardiac pacemakers
* no implanted cardioverter defibrillator
* no magnetically-activated implant or device
* no neurostimulation system
* no s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in spine bone marrow fat content
Timeframe: 36 weeks
2
Changes in hip bone marrow fat content
Timeframe: 36 weeks
3
Correlation of lumbar spine bone marrow fat content with bone strength at baseline
Timeframe: baseline - 0 weeks of intervention
4
Correlation of hip bone marrow fat content with hip strength at baseline
Timeframe: baseline - 0 weeks of intervention
5
Correlation of the changes in spine bone marrow fat content with changes in spine bone strength
Timeframe: 36 weeks
6
Correlation of the changes in hip bone marrow fat content (%) with changes in hip bone strength (N)