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Hormone Therapy
DHEA + Exercise for Osteoporosis
N/A
Waitlist Available
Led By Julio Carballido-Gamio, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a hormone called DHEA and specific exercises can help improve bone strength in older women with bone loss. The study will look at how these treatments affect bone marrow fat, which is important for bone health. The goal is to find new ways to prevent fractures and improve treatment for osteoporosis. DHEA has been studied for its potential benefits in bone health, including increasing bone mineral density and promoting osteoblast activity.
Who is the study for?
Postmenopausal women aged 55-85 with low bone mass or moderate osteoporosis, not currently doing high impact exercise more than twice a week, willing to do a 36-week exercise program and take DHEA or placebo. Must have completed COVID vaccination, no severe health issues like uncontrolled diabetes, recent cancer treatment (except skin cancer), heart disease, or metal implants if participating in MRI study.
What is being tested?
The trial is testing the effects of the hormone DHEA and an exercise program on bone marrow fat among older women with bone loss. The goal is to understand how these interventions could improve bone strength by affecting the microenvironment within bones over a period of 36 weeks.
What are the potential side effects?
Potential side effects from taking DHEA may include oily skin, acne, hair loss, stomach upset, high blood pressure changes in menstrual cycle for those who are not fully menopausal. Exercise might cause muscle soreness or injury if not done properly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in hip bone marrow fat content
Changes in spine bone marrow fat content
Correlation of hip bone marrow fat content with hip strength at baseline
+3 moreOther study objectives
spatial distribution of the changes in bone marrow fat content of the hip
spatial distribution of the changes in bone marrow fat content of the spine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: no exercise and placeboExperimental Treatment2 Interventions
no supervised bone-loading exercise and one placebo pill per day for 36 weeks
Group II: no exercise and DHEAExperimental Treatment2 Interventions
no supervised bone exercise and one dose of DHEA (50 milligrams) per day for 36 weeks
Group III: Exercise and placeboExperimental Treatment2 Interventions
supervised bone-loading exercise 3 days per week and one placebo pill per day for 36 weeks
Group IV: Exercise and DHEAExperimental Treatment2 Interventions
supervised bone-loading exercise 3 days per week and one dose of DHEA (50 milligrams) per day for 36 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DHEA
2004
Completed Phase 4
~2300
Exercise
2016
Completed Phase 1
~820
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Dehydroepiandrosterone (DHEA) acts as a hormonal precursor for estrogens and androgens, which are crucial for bone health. DHEA promotes osteoblast differentiation and increases bone mineral density (BMD) by up-regulating osteoblast-related genes and enhancing the activity of Foxp3(+) regulatory T cells.
Bone-loading exercises, on the other hand, provide mechanical stimulation that enhances bone formation and increases BMD by promoting the activity of osteoblasts. These mechanisms are vital for osteoporosis patients as they help improve bone strength, reduce the risk of fractures, and counteract the bone loss associated with the condition.
Whole-body vibration exercise in postmenopausal osteoporosis.DHEA promotes osteoblast differentiation by regulating the expression of osteoblast-related genes and Foxp3(+) regulatory T cells.Dehydroepiandrosterone administration increased trabecular mass and dihydrotestosterone levels in the cancellous region of the tibia in young female rats.
Whole-body vibration exercise in postmenopausal osteoporosis.DHEA promotes osteoblast differentiation by regulating the expression of osteoblast-related genes and Foxp3(+) regulatory T cells.Dehydroepiandrosterone administration increased trabecular mass and dihydrotestosterone levels in the cancellous region of the tibia in young female rats.
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,804 Previous Clinical Trials
2,822,125 Total Patients Enrolled
11 Trials studying Osteoporosis
1,085 Patients Enrolled for Osteoporosis
Julio Carballido-Gamio, PhDPrincipal InvestigatorUniversity of Colorado, Denver
Catherine Jankowski, PhDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
189 Total Patients Enrolled
2 Trials studying Osteoporosis
186 Patients Enrolled for Osteoporosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must be willing to exercise moderately for 36 weeks, and slowly increase the intensity over time.You do not have a device called an implanted cardioverter defibrillator.You haven't been doing strength training or high-impact weight-bearing exercises like jogging at least two days a week for the past six months.You are known to be afraid of small, enclosed spaces if you choose to participate in the MRI study.You are not using "triggerfish" contact lenses.You do not have a gastric reflux device.Your hematocrit level is over 54%.Your kidney function is below a certain level, based on a specific calculation.Your diabetes is not well controlled, with a high HbA1c level or if you are using insulin.You have osteoporosis that was caused by another health condition.You are in good physical shape, as confirmed by a score higher than 9 on a physical performance test.You have not had a menstrual period for at least 5 years.You have had breast, ovarian, metastatic endometrial, or cervical cancer in the past.You have had cancer treatment in the past 3 years, except for non-melanoma skin cancers.Women between 55 and 85 years old.You can walk without needing help from devices like canes or walkers.You have moderate osteoporosis and have refused the standard treatment for it.You do not have any implanted devices for nerve stimulation.You do not have a cochlear implant.Your blood pressure is not well controlled, and is consistently higher than 150/90 mmHg.You have a lung disease that required taking oral steroids or using extra oxygen in the past 6 months.You do not have a magnetically-activated implant or device in your body.You have been hospitalized for COVID-19 in the past.You do not have a fear of small or enclosed spaces.You have been diagnosed with heart disease or have symptoms like chest pain or irregular heartbeat without a clear evaluation by a heart specialist.You have severe joint problems that make it really hard to do moderate to intense exercise, even with special adjustments.You had hip or knee surgery, or spinal surgery in the last 6 months.You are currently receiving physical therapy for your legs.Your vitamin D levels are lower than 20 ng/mL. You may be reconsidered for the study after taking vitamin D supplements as directed by the study's protocol.Your thyroid hormone levels are too low or too high without showing signs or symptoms of a thyroid problem. If you have abnormal levels, your doctor will need to check and possibly treat it before you can join the study.Your liver function tests show signs of acute liver disease with levels of certain enzymes higher than normal.You have not used DHEA supplements or sex hormones in the past 6 months. Using low dose vaginal estrogen creams 3 days per week or less is okay.Your bone density in your lower back, hip, or thigh bone is very low.You have broken a bone because of weak bones.You currently smoke cigarettes.You are experiencing vaginal bleeding that has not been diagnosed by a doctor.You have a history of memory problems or have scored less than 4 on a certain memory test.You have low bone density in your spine, hip, or femoral neck.You have not been regularly doing strength training or high-impact weight-bearing exercises, like jogging, at least two days a week for the last six months.You have moderate osteoporosis and have refused standard treatment for it.You had a mammogram in the last year that didn't show any signs of breast cancer.You do not have a device for treating gastric reflux.You are not using an insulin pump.You do not have temporary heart pacing wires in place.You do not have any aneurysm clips in your body.You do not have a neurostimulation device implanted in your body.You do not have a spinal cord stimulator.You do not have a cochlear implant.Women between 55 and 85 years old.You agree to take either a daily pill of DHEA (50mg/d) or a pill that does nothing (placebo) for up to 36 weeks without knowing which one you are taking.You do not have any metal objects in your eye.You cannot wear 'triggerfish' contact lenses.You are not using a device that helps bones grow or fuse together.You have been diagnosed with serious heart problems like heart failure, severe aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia.Your blood triglyceride levels are higher than 400 mg/dL when you haven't eaten anything.Your blood test shows low levels of DHEAS hormone.You are not using a bone growth or fusion device.You have taken certain medications that affect bone health in the past 6 months.You are not frail, as shown by scoring above 9 on a physical performance test.You don't have any metal objects in your eye.You don't have any metal or electronic implants in your body.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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