CLINICAL TRIAL

Treatment for Osteoporosis, Postmenopausal

Recruiting · 18+ · Female · Aurora, CO

This study is evaluating whether a hormone replacement therapy may help improve bone health in older women.

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About the trial for Osteoporosis, Postmenopausal

Eligible Conditions
Osteoporosis · Low Bone Mass · Osteoporosis, Postmenopausal

Treatment Groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Control Group 1
DHEA
OTHER
+
Exercise
BEHAVIORAL
Control Group 2
Exercise
BEHAVIORAL
+
Placebo
OTHER
Control Group 3
DHEA
OTHER

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:
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;
You are not performing resistance exercise training or high impact weight-bearing exercise (e.g. show original
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).
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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
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 Treatment will improve 1 primary outcome and 13 secondary outcomes in patients with Osteoporosis, Postmenopausal. Measurement will happen over the course of Baseline and 36 Weeks.

Change in Proximal femur strength, stance model
BASELINE AND 36 WEEKS
mean change from baseline in the estimated strength of the proximal femur in a stance model
BASELINE AND 36 WEEKS
Change in Vertebral (L1-2) strength, fall model
BASELINE AND 36 WEEKS
mean change from baseline in the estimated strength of L1-2 vertebrae in a fall model
BASELINE AND 36 WEEKS
Change in Total body fat-free mass
BASELINE AND 36 WEEKS
mean change from baseline in total body fat-free mass
BASELINE AND 36 WEEKS
Change in Proximal femur strength, fall model
BASELINE AND 36 WEEKS
mean change from baseline in the estimated strength of the proximal femur in a fall model
BASELINE AND 36 WEEKS
Change in Vertebral (L1-2) cortical vBMD
BASELINE AND 36 WEEKS
mean change from baseline in vertebral cortical volumetric BMD
BASELINE AND 36 WEEKS
Change in Vertebral (L1-2) total volumetric bone mineral density (vBMD)
BASELINE AND 36 WEEKS
mean change from baseline in vertebral total volumetric BMD
BASELINE AND 36 WEEKS
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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.

How many people get osteoporosis, postmenopausal a year in the United States?

Results from a recent paper indicates that nearly a quarter of women receive a diagnosis of osteoporosis in any given year. The reasons for these trends need to be determined. While the number of patients affected by postmenopausal osteoporosis has been clearly defined, patients with idiopathic postmenopausal osteopenia are not adequately diagnosed and treated. These patients are at higher risk of osteoporotic fracture.

Anonymous Patient Answer

Can osteoporosis, postmenopausal be cured?

Osteoporosis prevention is important after menopause. An early evaluation and effective intervention can prevent the occurrence of osteopenia and osteoporosis while treating other osteopenic characteristics, such as vertebral fractures, postmenopausal arthritis and osteopenia, and is especially important for younger patients who are at risk.

Anonymous Patient Answer

What causes osteoporosis, postmenopausal?

Postmenopausal women with osteoporosis have higher rates of cardiovascular mortality, noncancer death and major CV events, and the cause of CVD death and noncancer mortality is not attributable to OV.

Anonymous Patient Answer

What is osteoporosis, postmenopausal?

The most common bone defects encountered by surgeons are osteoporotic fractures. The osteoporotic fractures most common to surgeons are the proximal radius fractures and distal tibia fractures. If the patient has a history or findings of osteoporosis, and is elderly, it is recommended that they have a bone density scan on the basis of a fracture.

Anonymous Patient Answer

What are common treatments for osteoporosis, postmenopausal?

About one third of women have osteoporosis. Common treatments for postmenopausal women with osteoporosis and osteopenia include estrogen replacement therapy and calcium and vitamin D supplements. Although these medications may provide some protection, they do not address risk in early postmenopause.\n

Anonymous Patient Answer

What are the signs of osteoporosis, postmenopausal?

The main symptoms of osteoporosis include a low bone mineral density (BMD), long bone fracture and spinal stenosis (narrowing of the discs), all of which can be treated. Other symptoms may include a painful joint, numbness and tingling, fatigue and backache. In children, it may cause bowing of the growth plate and bone malformation.\n\nIf you are diagnosed with any of the symptoms above, seek medical attention immediately and get yourself to the doctor immediately (you may not remember exactly what the exact symptoms were).

Anonymous Patient Answer

Who should consider clinical trials for osteoporosis, postmenopausal?

There is no reliable epidemiologic evidence on the prevalence of osteoporosis and its complication in an elderly population. As there are no guidelines (e.g., the guidelines of the Dutch College of General Practitioners and the German Society of Internal Medicine) for deciding when to start a clinical trial on osteoporosis, the treatment decisions should be based on the individual history of the patient, medical history of the patient, available treatment options, and the patient's desires in regard to the treatments.

Anonymous Patient Answer

What is treatment?

There are a number of treatment options available to individuals diagnosed with osteoporosis, but the most widely cited evidence-based treatment recommendations are the bisphosphonate medications. [The American College of Physicians recognizes] the evidence for these medications is strongest for treatment of moderate to severe osteoporosis, where there is a demonstrable reduction in fracture risk and fracture number when provided for at least three years. [When medications are used at a low enough dose to reduce fractures but not at a level that reduces normal skeletal turnover, then it is considered a “pharmacologic fracture” in the medical community.

Anonymous Patient Answer

How does treatment work?

Recent findings highlights that no single mechanism can explain the antiresorptive effects of alendronate, which were seen with all treatments. This suggests that alendronate exerts its antiresorptive effects by a multitude of mechanisms involving, not only changes in bone turnover, but also increased osteoprotegerin levels, which inhibit the effects of osteoclasts, bone resorption, thus leading to a reduction in bone mass. The authors conclude that treatment modalities, besides the timing and regimen, may play a significant role in determining which patient gets antiresorptive treatment, and thus how well the alendronate achieves its antiresorptive effects.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

Most research has provided evidence to support the use of treatment to prevent osteoporosis and fracture. These treatments include alendronate, risedronate, estrogens, bisphosphonates, raloxifene, hormone replacement therapy, estrogens alone or with a selective estrogen receptor modulator, and phytehormone treatment. As a result of these findings, the U.S.

Anonymous Patient Answer

How serious can osteoporosis, postmenopausal be?

Osteoporosis in postmenopausal women is a significant health problem. Patients should be aware of the risks of developing osteoporosis, and the value of monitoring their bone mineral density should be emphasized.

Anonymous Patient Answer

Is treatment safe for people?

Evidence in favour of the use of FRAX® calculator, as opposed to clinical judgment, in guiding osteoporosis treatment, was presented, based on the fact that both groups had similar rate of treatment initiation, occurrence of major adverse events, and no major adverse events were recorded in the FRAX group. We agree with this finding and suggest that such evidence is potentially worthy of a larger review. Further research is needed to investigate what effect the use of FRAX calculator could have on the decision to initiate treatment, in the light of the large number of people who do not receive treatment for osteoporosis each year in the UK.

Anonymous Patient Answer
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