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Hormone Therapy
DHEA + Exercise for Osteoporosis
N/A
Recruiting
Led By Catherine Jankowski, 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
Refusal of standard osteoporosis treatment in women with moderate osteoporosis (BMD t-scores >=-3.0 and =< 2.5)
Non-frail, as determined by short physical performance battery (SPPB) score > 9 (0-12 scale)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights
Study Summary
This trial is testing whether bone-loading exercise and DHEA supplements can help improve bone health in older women with low or moderate osteoporosis.
Who is the study for?
Women aged 60-85 with low bone mass or moderate osteoporosis, willing to take DHEA or a placebo and participate in an exercise program for 36 weeks. They must have had their last menstrual period at least 5 years ago, be non-smokers, not on certain medications affecting bone metabolism, and able to live in Denver for the study duration.Check my eligibility
What is being tested?
The trial is testing if taking DHEA orally and doing bone-loading exercises can improve musculoskeletal health in older women with low bone density. Participants will either receive DHEA supplements or a placebo while following an exercise regimen.See study design
What are the potential side effects?
Potential side effects of DHEA may include oily skin, hair loss, stomach upset, high blood pressure, changes in menstrual cycle (if applicable), facial hair growth in women, fatigue and nasal congestion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have refused standard treatments for my moderate osteoporosis.
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I am not considered frail based on a physical performance test.
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I can walk without any help or devices.
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
Change in lumbar spine aBMD
Secondary outcome measures
Change in Femoral cortical vBMD
Change in Femoral total vBMD
Body Weight Changes
+10 moreTrial Design
3Treatment groups
Active Control
Group I: DHEA onlyActive Control1 Intervention
1 study pill containing 50 mg of DHEA daily for 36 weeks
Group II: Exercise and DHEAActive Control2 Interventions
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.
Group III: Exercise and PlaceboActive Control2 Interventions
1 study pill containing placebo daily for 36 weeks and supervised bone-loading exercise on 3 days per week for 36 weeks.
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,323 Total Patients Enrolled
11 Trials studying Osteoporosis
1,007 Patients Enrolled for Osteoporosis
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,839 Total Patients Enrolled
22 Trials studying Osteoporosis
12,043 Patients Enrolled for Osteoporosis
Catherine Jankowski, PhDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
89 Total Patients Enrolled
2 Trials studying Osteoporosis
86 Patients Enrolled for Osteoporosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used DHEA or sex hormones in the last 6 months, except for low dose vaginal estrogen creams.I have experienced vaginal bleeding without a known cause.I have refused standard treatments for my moderate osteoporosis.Your blood test shows low levels of DHEAS, a hormone in your body.My thyroid function is not normal, but I don't have symptoms.Your blood test shows high levels of triglycerides after fasting.I have severe joint problems that prevent me from doing intense workouts.I haven't taken any medications that affect bone health in the last 6 months.You are currently smoking cigarettes.I am not considered frail based on a physical performance test.It has been over 5 years since my last menstrual period.I am open to being assigned to either an exercise or a no-exercise group in the study.I have been hospitalized for COVID-19 before.I have had COVID-19 symptoms or a positive test within the last 10 days.My blood pressure is not higher than 150/90 mmHg, or it's controlled with medication.I do not have unstable heart disease or untreated arrhythmias.I have heart failure, severe aortic valve narrowing, uncontrolled chest pain, or irregular heartbeats.I've needed oral steroids or extra oxygen for my lung condition in the last 6 months.I have not had hip or knee surgery, or spinal surgery in the last 6 months.My liver tests are higher than normal.My kidney function is reduced, with an eGFR below 45.I have had breast, ovarian, endometrial, or cervical cancer.I can walk without any help or devices.My doctor thinks I can't safely do the exercise because of my physical condition.I am willing to commit to a 36-week exercise program.You need to score 4 or higher on a test to show that you can think clearly.I have been diagnosed with osteoporosis caused by another condition.You must have had a normal mammogram within the last year.Your hematocrit level is above 54%.I am willing to take a daily pill without knowing if it's DHEA or a placebo for up to 36 weeks.You haven't been doing strength training or high-impact exercises like jogging at least 2 days a week for the last 6 months.Your bone density test scores in your lower back, hip, or thigh are very low.You have a history of memory problems or difficulty thinking, or you score less than 4 on a memory test.Your bones are weaker than they should be, based on a specific bone density test.I use insulin.I have not had cancer treatment in the last 3 years, except for non-melanoma skin cancers.My vitamin D level is below 20 ng/mL, but I can start or adjust vitamin D supplements as advised.I am currently in physical therapy for my legs.My diabetes is not well-managed, with HbA1c over 8.5% or I use insulin.
Research Study Groups:
This trial has the following groups:- Group 1: DHEA only
- Group 2: Exercise and DHEA
- Group 3: Exercise and Placebo
Awards:
This trial has 0 awards, including: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.
How many people are enrolled in the current research endeavor?
"Affirmative. From clinicaltrials.gov, one can observe that this medical research study is actively looking for participants. This trial was first posted on December 2nd 2018 and the most recent update occured on February 14th 2022 with a target of 225 patients to be recruited from 1 centre."
Answered by AI
Is the age threshold for this analysis limited to those under 35 years old?
"This clinical trial has established that patients aged between 55 to 85 are eligible for participation. For those below 18, a seperate 15 trials have been organised while 120 studies accommodate seniors aged above 65."
Answered by AI
Who possesses the requisite criteria to join this trial?
"In order to be part of this medical trial, participants must have postmenopausal osteoporosis and belong to the 55-85 age demographic. Roughly 225 individuals are being sought out for enrollment."
Answered by AI
Are participants still being welcomed into this investigation?
"Clinicaltrials.gov shows that this medical study is still open to participants, with the initial post dating back to February 12th 2018 and last updated on February 14th 2022."
Answered by AI
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