Trials / Completed
CompletedNCT03227458
DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- Female
- Age
- 55 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
To determine whether the musculoskeletal adaptations to bone-loading exercise can be significantly augmented in older women (aged 60-85) with low bone mass (osteopenia; T-scores \<-1.0 and \>-2.5) or moderate osteoporosis (T-scores \< -2.5 and \>= -3.0) and by restoring serum DHEAS to young adult levels by oral DHEA replacement.
Detailed description
This will be the first study to measure changes in areal bone mineral density (aBMD) and fat-free mass (FFM) in response to dehydroepiandrosterone (DHEA) alone and combined with exercise in postmenopausal women. The body of evidence from carefully executed Randomized Controlled Studies (RCTs) provides support for DHEA therapy to increase aBMD and FFM in older women. Less is known about whether DHEA therapy enhances the effects of exercise on the aging musculoskeletal system when an appropriate mechanical stimulus is applied.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | DHEA | Participants will take 1 study pill (50 mg DHEA) daily for 36 weeks. |
| OTHER | Placebo | Participants will take placebo daily for 36 weeks. |
| BEHAVIORAL | Exercise | bone-loading exercise on 3 days per week for 38 weeks |
Timeline
- Start date
- 2018-02-12
- Primary completion
- 2024-06-19
- Completion
- 2024-06-19
- First posted
- 2017-07-24
- Last updated
- 2024-12-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03227458. Inclusion in this directory is not an endorsement.