CLINICAL TRIAL

DHEA for Low Bone Density

EnrollingByInvitation · 18+ · Female · Aurora, CO

Effects of DHEA and Exercise on Bone Marrow Fat in Postmenopausal Women

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About the trial for Low Bone Density

Eligible Conditions
Low Bone Density · Osteoporosis · Bone Diseases, Metabolic

Treatment Groups

This trial involves 4 different treatments. DHEA is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
DHEA
DIETARYSUPPLEMENT
+
Exercise
BEHAVIORAL
Experimental Group 2
DHEA
DIETARYSUPPLEMENT
+
Exercise
BEHAVIORAL
Experimental Group 3
DHEA
DIETARYSUPPLEMENT
+
Exercise
BEHAVIORAL
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DHEA
2004
Completed Phase 4
~2080
Exercise
2016
Completed Phase 1
~1010

Eligibility

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
women aged 55 to 85 years
non-frail, as determined by Short Physical Performance Battery 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 take DHEA (50mg/d) or a placebo pill daily and remain blinded for up to 36 weeks
You are not exercising 2 or more days per week in the past 6 months. show original
ambulatory without assistive devices
serum DHEAS < 140 μg/dL (3.8 μmol/L)
low bone mass or moderate osteoporosis indicated by lumbar spine, total hip, or femoral neck aBMD t-scores < -1.0 and ≥ -3.0
refusal of standard osteoporosis treatment in women with moderate osteoporosis (BMD ≥-3.0 and ≤ -2.5)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 36 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 36 weeks.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether DHEA will improve 6 primary outcomes and 2 other outcomes in patients with Low Bone Density. Measurement will happen over the course of baseline - 0 weeks of intervention.

Correlation of lumbar spine bone marrow fat content with bone strength at baseline
BASELINE - 0 WEEKS OF INTERVENTION
Correlation of lumbar bone marrow fat content (%) with strength (N) of the lumbar spine at baseline
Correlation of hip bone marrow fat content with hip strength at baseline
BASELINE - 0 WEEKS OF INTERVENTION
Correlation of proximal femur spine bone marrow fat content (%) with strength (N) of the proximal femur at baseline
Changes in spine bone marrow fat content
36 WEEKS
changes in bone marrow fat content of the lumbar spine
Correlation of the changes in hip bone marrow fat content (%) with changes in hip bone strength (N)
36 WEEKS
Correlation of the changes in proximal femur bone marrow fat content (%) with changes in proximal femur bone strength (N)
Correlation of the changes in spine bone marrow fat content with changes in spine bone strength
36 WEEKS
Correlation of the changes in lumbar spine bone marrow fat content (%) with changes in lumbar spine strength (N)
spatial distribution of the changes in bone marrow fat content of the hip
36 WEEKS
spatial distribution of the changes in bone marrow fat content of the proximal femur
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can osteopenia be cured?

Even though osteopenia is a very low-risk condition, in the absence of significant symptoms and signs, one can be reassured and consider avoiding medications, especially biostimulants that may accelerate bone loss, and exercising regularly.

Anonymous Patient Answer

How many people get osteopenia a year in the United States?

About 18.7% of the US population is osteopenic (with osteoporosis at some point in their life). About 17.4% of men in the US are osteopenic. Younger people tend to be less likely to be osteopenic or have a lower prevalence of osteopenia. The absolute number of new cases of osteopenia (including new cases of osteoporosis) could be substantial.

Anonymous Patient Answer

What are the signs of osteopenia?

Signs of osteopenia include the following: bone pain, unexplained loss of height or weight, lower than expected BMD on imaging, osteoporosis, and abnormal fracture healing.

Anonymous Patient Answer

What causes osteopenia?

In this population, the most common precipitating factor involved in the development of osteopenia was recent chemotherapy. Osteopenia developed quickly, was responsive to increased calcium intake, and the response appeared to be maintained 3 years after therapy had been discontinued.

Anonymous Patient Answer

What is osteopenia?

Osteopenia is defined as an absolute or relative bone mineral density of 20 or less than the upper limit of the age and gender matched reference values without the use of dual x-ray absorptiometry. A population-based osteopenia screening should be offered to adults who had no baseline risk factors for osteopenia because of the high incidence of unrecognized osteopenia and low fracture rate when the test is positive.

Anonymous Patient Answer

What are common treatments for osteopenia?

The most common treatment for osteopenia is multivitamin therapy. Regular physical therapy is useful and can be combined with aerobic exercise to improve bone turnover. Exercise is a safe alternative therapy and is recommended, for example, in patients with knee pain and knee osteoarthritis. For osteoporosis prevention, osteocalcin can be used.

Anonymous Patient Answer

How serious can osteopenia be?

Patients with osteopenia on the whole are unlikely to have fracture. A more careful definition of osteopenia which identifies the frail elderly may identify patients who would benefit from prevention and intervention programs.

Anonymous Patient Answer

Is dhea safe for people?

Despite the risks it presents, DHEA was a safe and effective treatment in this population. The side effects were well tolerated, and the potential for a risk of osteopenia or osteoporosis in menorrhagia is an interesting observation, and could be a significant clinical issue.

Anonymous Patient Answer

Does dhea improve quality of life for those with osteopenia?

A nutritional intervention delivered through nutritional supplements containing DHEA improved BMD but did not improve quality of life in women with low levels of BMD.

Anonymous Patient Answer

Is dhea typically used in combination with any other treatments?

In patients with advanced stages of GCXD deficiency that resulted in delayed tooth eruption, an individual treatment of dental extractions in combination with a treatment of DHEA may be beneficial. However, further well-designed clinical studies are needed.

Anonymous Patient Answer

Has dhea proven to be more effective than a placebo?

Dhea can be safely and effectively prescribed to patients with osteoporosis who are at high risk for developing osteoporotic fractures and are currently on stable or intermittent exogenous estrogen therapy. Dhea should be part of a comprehensive treatment protocol for osteoporosis including calcium, bisphosphonates, and adequate hormone therapy.

Anonymous Patient Answer

What are the latest developments in dhea for therapeutic use?

Dhea and its derivatives have shown significant effects in clinical trials. Dhea and its derivatives have been shown to be well tolerated and safe for use in clinical studies.

Anonymous Patient Answer
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