Low Bone MassNCT03227458
DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women
A study testing DHEA and Exercise in people with Low Bone Mass and Osteoporosis, Postmenopausal, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Bone Mass, Osteoporosis, Postmenopausal
- What is being tested?
- DHEA and Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 19 Jun 2024
- Phase
- Interventional
- 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 55 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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 10 days before study entry; or has had fever within the past 3 days and respiratory symptoms have not improved; or symptoms first appeared less than 10 days before study entry
- uncontrolled hypertension defined as resting systolic blood pressure (sBP) >150 mmHg or diastolic blood pressure (dBP) >90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including follow-up evaluation by their Primary Care Physician (PCP) with initiation or adjustment of anti-hypertensive medications;
- diagnosed ischemic heart disease or indicators of unstable ischemic heart disease (e.g., angina, ST segment depression) or arrhythmias at rest or during the Gated Exercise Test (GXT) without negative follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist;
- diagnosis of heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia.
- pulmonary disease requiring use of oral steroids within the previous 6 months or the use of supplemental oxygen ≥ 4 liters with physical exertion
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- orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that greatly limit the ability to perform moderate to high intensity resistance exercise (e.g., unable to be properly positioned in exercise equipment or to have severely restricted range of motion even after modifications have been made)
- hip fracture, hip or knee replacement, or spinal surgery in the past 6 months;
- undergoing physical therapy involving the lower extremities;
- hematocrit (HCT) > 54%;
- thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) < 0.4 or > 10.0 microunits/mL;, without signs or symptoms of clinical hypo- or hyperthyroidism. Volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by their PCP with initiation or adjustment of thyroid hormone replacement;
- acute liver disease indicated by liver function tests (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase) ≥ 1.5 times the upper limits of normal;
- estimated glomerular filtration rate (eGFR) < 45, using the Modification of Diet in Renal Disease (MDRD) equation (Levey et al, Annals Inter Med, 1999; Munter et al, Clin J Am Soc Nephrology, 2009);
- poorly controlled diabetes mellitus based on HbA1c > 8.5%, or use of insulin;
- fasted serum triglycerides > 400 mg/dL;
- serum 25-hydroxy vitamin D <20 ng/mL; volunteers will be re-considered for participation in the study after follow-up evaluation by their PCP with initiation or adjustment of vitamin D supplementation per the study's vitamin D repletion protocol.
- use of DHEA supplementation or sex hormones in the past 6 months. Use of prescription low dose vaginal estrogen creams (Premarin or Estrace) 3 days per week will not be exclusionary.
- use in the past 6 months of any medications known to alter bone metabolism (e.g., oral glucocorticoids, bone anti-resorptive agents);
- documented history of cognitive impairment or dementia, or Mini-Cog < 4;
- current smoker;
- personal history of breast, ovarian, metastatic endometrial, or cervical cancer;
- any cancer requiring treatment in the past 3 years except non-melanoma skin cancers;
- un-diagnosed vaginal bleeding;
- women who, in the judgment of the study physician, appear incapable of safely participating in the exercise (e.g., neuromuscular/musculoskeletal impairment)
- use of insulin;
- lumbar spine, total hip, or femoral neck aBMD t-scores < -3.0;
- secondary osteoporosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
Read the 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
- Low Bone Mass, Osteoporosis, Postmenopausal
- Being tested
- DHEA, Placebo, Exercise
- Keywords
- areal bone mineral density, dehydroepiandrosterone (DHEA), postmenopause, exercise, sex hormones
- Medical subject headings
- Osteoporosis, Postmenopausal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEAOther
Also called DHEA therapy
Participants will take 1 study pill (50 mg DHEA) daily for 36 weeks.
PlaceboOther
Participants will take placebo daily for 36 weeks.
ExerciseBehavioural
Also called bone-loading exercise
bone-loading exercise on 3 days per week for 38 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercise and DHEA | Active comparator | 1 study pill containing 50 mg of DHEA daily for 36 weeks and supervised bone-loading exercise on 3 days per week for 36 weeks. Receives: Other: DHEA; Behavioral: Exercise |
| Exercise and Placebo | Active comparator | 1 study pill containing placebo daily for 36 weeks and supervised bone-loading exercise on 3 days per week for 36 weeks. Receives: Other: Placebo; Behavioral: Exercise |
| DHEA only | Active comparator | 1 study pill containing 50 mg of DHEA daily for 36 weeks Receives: Other: DHEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lumbar spine aBMD
mean change from baseline in lumbar spine aBMD
Measured: Baseline and 36 Weeks
Secondary outcomes (13)
Change in total hip aBMD
mean change from baseline in total hip aBMD
Measured: 36 Weeks
Change in regional hip aBMD
mean change from baseline in regional hip aBMD
Measured: Baseline and 36 Weeks
Change in Vertebral (L1-2) total volumetric bone mineral density (vBMD)
mean change from baseline in vertebral total volumetric BMD
Measured: Baseline and 36 Weeks
Change in Vertebral (L1-2) cortical vBMD
mean change from baseline in vertebral cortical volumetric BMD
Measured: Baseline and 36 Weeks
Change in Vertebral (L1-2) trabecular vBMD
mean change from baseline in vertebral trabecular volumetric BMD
Measured: Baseline and 36 Weeks
Change in Femoral total vBMD
mean change from baseline in femoral total volumetric BMD
Measured: Baseline and 36 Weeks
Change in Femoral cortical vBMD
mean change from baseline in femoral cortical volumetric BMD
Measured: Baseline and 36 Weeks
Change in Femoral trabecular vBMD
mean change from baseline in femoral trabecular volumetric BMD
Measured: Baseline and 36 Weeks
Change in Vertebral (L1-2) strength, stance model
mean change from baseline in the estimated strength of L1-2 vertebrae in a stance model
Measured: Baseline and 36 Weeks
Change in Vertebral (L1-2) strength, fall model
mean change from baseline in the estimated strength of L1-2 vertebrae in a fall model
Measured: Baseline and 36 Weeks
Change in Proximal femur strength, stance model
mean change from baseline in the estimated strength of the proximal femur in a stance model
Measured: Baseline and 36 Weeks
Change in Proximal femur strength, fall model
mean change from baseline in the estimated strength of the proximal femur in a fall model
Measured: Baseline and 36 Weeks
Change in Total body fat-free mass
mean change from baseline in total body fat-free mass
Measured: Baseline and 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start12 Feb 2018
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Bone MassStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will take 1 study pill (50 mg DHEA or placebo: double-blinded) daily for 36 weeks. The research pharmacist will dispense study drug according to the randomization code and maintain drug dispensation records, which will be monitored by the study biostatistician. Two-thirds of participants will engage in bone-loading exercise 3 days per week for the 36 weeks.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Catherine Jankowski, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227458
- Sponsor's protocol ID
- 16-2427
- Other IDs
- 5R01AG053489-05
- Status last verified
- Dec 2024
- First submitted
- 20 Jul 2017
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DHEA Augmentation of Musculoskeletal Adaptations to Exercise in Older Women
- ClinicalTrials.gov ID
- NCT03227458
- Acronym / sponsor ID
- 16-2427
- Conditions
- Low Bone Mass, Osteoporosis, Postmenopausal
- Keywords
- areal bone mineral density, dehydroepiandrosterone (DHEA), postmenopause, exercise, sex hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 24 Jul 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- All participants will take 1 study pill (50 mg DHEA or placebo: double-blinded) daily for 36 weeks. The research pharmacist will dispense study drug according to the randomization code and maintain drug dispensation records, which will be monitored by the study biostatistician. Two-thirds of participants will engage in bone-loading exercise 3 days per week for the 36 weeks.
| Arm | Type | Receives |
|---|---|---|
| Exercise and DHEA | Active comparator | Other: DHEA, Behavioral: Exercise1 study pill containing 50 mg of DHEA daily for 36 weeks and supervised bone-loading exercise on 3 days per week for 36 weeks. |
| Exercise and Placebo | Active comparator | Other: Placebo, Behavioral: Exercise1 study pill containing placebo daily for 36 weeks and supervised bone-loading exercise on 3 days per week for 36 weeks. |
| DHEA only | Active comparator | Other: DHEA1 study pill containing 50 mg of DHEA daily for 36 weeks |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (27 listed)
- 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 10 days before study entry; or has had fever within the past 3 days and respiratory symptoms have not improved; or symptoms first appeared less than 10 days before study entry
- uncontrolled hypertension defined as resting systolic blood pressure (sBP) >150 mmHg or diastolic blood pressure (dBP) >90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including follow-up evaluation by their Primary Care Physician (PCP) with initiation or adjustment of anti-hypertensive medications;
- diagnosed ischemic heart disease or indicators of unstable ischemic heart disease (e.g., angina, ST segment depression) or arrhythmias at rest or during the Gated Exercise Test (GXT) without negative follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist;
- diagnosis of heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia.
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: DHEA therapyParticipants will take 1 study pill (50 mg DHEA) daily for 36 weeks. | Other | DHEA only, Exercise and DHEA |
| PlaceboParticipants will take placebo daily for 36 weeks. | Other | Exercise and Placebo |
| ExerciseAlso: bone-loading exercisebone-loading exercise on 3 days per week for 38 weeks | Behavioural | Exercise and DHEA, Exercise and Placebo |
Primary outcome
Change in lumbar spine aBMD
Time frame: Baseline and 36 Weeks
mean change from baseline in lumbar spine aBMD
13 secondary outcomes
Change in total hip aBMD
Time frame: 36 Weeks
Change in regional hip aBMD
Time frame: Baseline and 36 Weeks
Change in Vertebral (L1-2) total volumetric bone mineral density (vBMD)
Time frame: Baseline and 36 Weeks
Change in Vertebral (L1-2) cortical vBMD
Time frame: Baseline and 36 Weeks
Change in Vertebral (L1-2) trabecular vBMD
Time frame: Baseline and 36 Weeks
Change in Femoral total vBMD
Time frame: Baseline and 36 Weeks
Change in Femoral cortical vBMD
Time frame: Baseline and 36 Weeks
Change in Femoral trabecular vBMD
Time frame: Baseline and 36 Weeks
Change in Vertebral (L1-2) strength, stance model
Time frame: Baseline and 36 Weeks
Change in Vertebral (L1-2) strength, fall model
Time frame: Baseline and 36 Weeks
Change in Proximal femur strength, stance model
Time frame: Baseline and 36 Weeks
Change in Proximal femur strength, fall model
Time frame: Baseline and 36 Weeks
Change in Total body fat-free mass
Time frame: Baseline and 36 Weeks
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 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Catherine Jankowski, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHEA and Exercise in people with Low Bone Mass and Osteoporosis, Postmenopausal, run by University of Colorado, Denver 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 13 inclusion and 27 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 5 Dec 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in lumbar spine aBMD (time frame: Baseline and 36 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2024.