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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
Study Summary
This trial will look at the effects of a common steroid hormone, DHEA, and exercise on bone marrow fat and bone strength in older women.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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
Exercise
2016
Completed Phase 1
~760
DHEA
2004
Completed Phase 4
~2080
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,531 Total Patients Enrolled
11 Trials studying Osteoporosis
1,180 Patients Enrolled for Osteoporosis
Julio Carballido-Gamio, PhDPrincipal InvestigatorUniversity of Colorado, Denver
Catherine Jankowski, PhDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
262 Total Patients Enrolled
2 Trials studying Osteoporosis
259 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who makes a viable participant for this clinical experiment?
"To qualify, applicants must have diminished bone density and be aged between 55 to 85 years. This research project is looking for approximately 52 participants in total."
Answered by AI
Does this clinical trial allow for participants aged 50 years or older?
"Applicants aged 55 to 85 are eligible for this medical trial. Meanwhile, there are 18 trials available for those under the age of majority and 137 options available for seniors above 65 years old."
Answered by AI
Are there any available positions for participants in this experiment?
"This research endeavour is no longer recruiting participants, as evidenced by the clinicaltrials.gov information which was last updated on March 30th 2022. Although this trial has concluded its recruitment period, there are 159 other studies actively looking for volunteers at present."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Illinois
Other
Georgia
How old are they?
18 - 65
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
Why did patients apply to this trial?
add to body of knowledge about osteoporosis. Making changes to have a healthier and better me.
PatientReceived 2+ prior treatments
I am very interested in excercising to prevent and improve osteoporosis. I've tried other methods for Osteoporosis treatment and really want to pursue a trial without the side effects of current medications. I've also worked hard on diet, and more natural approaches. Thank you.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
I would like to know how many times I would need to come to Colorado?
PatientReceived 1 prior treatment
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