DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women (NCT03227458) | Clinical Trial Compass
CompletedNot Applicable
DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women
United States152 participantsStarted 2018-02-12
Plain-language 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.
Who can participate
Age range55 Years – 85 Years
SexFEMALE
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Inclusion Criteria:
* non-frail, as determined by short physical performance battery (SPPB) 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 be randomized to an exercise or a no-exercise arm of the study;
* 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 defined as lumbar spine or proximal hip aBMD t-scores \< -1.0 and \> = -3.0;
* refusal of standard osteoporosis treatment in women with moderate osteoporosis (BMD t-scores \>=-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
* normal cognitive function, as determined by a Mini-Cog score \> = 4
Exclusion Criteria:
* history of hospitalization for Corona Virus Disease-19 (COVID-19)
* does not meet Centers for Disease Control and Prevention (CDC) recommendations for home isolation because has had a positive severe acute respiratory syndrome corona virus-2 (SARS-COV-2) test less than 1…