CLINICAL TRIAL

Prune for Osteoporosis

Recruiting · 18 - 65 · Female · San Diego, CA

This study is evaluating whether a specific type of plum may help prevent bone loss in young women who use oral contraceptives.

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About the trial for Osteoporosis

Eligible Conditions
Osteoporosis Risk · Osteoporosis

Treatment Groups

This trial involves 2 different treatments. Prune is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Prune
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for female patients between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 18-25
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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: At baseline, at 6 months, at 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: At baseline, at 6 months, at 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At baseline, at 6 months, at 12 months.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Prune will improve 1 primary outcome and 1 secondary outcome in patients with Osteoporosis. Measurement will happen over the course of At baseline, at 12 months.

Changes in bone mineral density from baseline to 12 months
AT BASELINE, AT 12 MONTHS
AT BASELINE, AT 12 MONTHS
Changes from baseline in bone specific alkaline phosphatase at 6 months and 12 months
AT BASELINE, AT 6 MONTHS, AT 12 MONTHS
AT BASELINE, AT 6 MONTHS, AT 12 MONTHS

Who is running the study

Principal Investigator
S. H.
Prof. Shirin Hooshmand, Professor
San Diego State University

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 a year in the United States?

About one million women and men over 55 have postmenopausal osteoporosis in the United States. Osteoporosis is the second most common cause of low bone mineral density in women and men.

Anonymous Patient Answer

What is the primary cause of osteoporosis?

Recent findings identified a primary cause of osteoporosis in more than 80% of women with primary sclerosing cholangitis. Recent findings demonstrated that a single biopsy is sufficient to characterize causes of osteoporosis in PSC, and that it is unnecessary to evaluate many women for the underlying cause of osteoporosis

Anonymous Patient Answer

What causes osteoporosis?

Osteoporosis is often a result of a lack of exposure of bone to estrogen in the early stages of puberty or a lack of exposure of bone to calcitriol later in life.

Anonymous Patient Answer

What are common treatments for osteoporosis?

Treatment for osteoporosis may include some of the same drugs, and may use some of the same therapies as mentioned for other bone diseases. The only difference to be considered is that for osteoporosis, the patient's height is measured each year and treatment is tailored solely on the patient's height, weight and BMD. Treatment recommendations should be based on the risk of fracture and the patient's preferences.\n

Anonymous Patient Answer

Can osteoporosis be cured?

Currently, no treatments can significantly improve the quality of life in people affected by osteoporosis. Although a number of new drugs have been shown to be effective in fracture prevention, a long-term effect by itself has not been demonstrated.

Anonymous Patient Answer

What is osteoporosis?

Although the mechanism leading to osteoporosis is well understood, the terminology used to describe the disease is not. It is recommended that osteoporosis be used in preference to 'bone loss' as, although this is the predominant terminology in North America, it is a misleading term because osteoporosis is a symptom rather than a disease in itself. Moreover, osteoporosis should ideally be distinguished from osteopenia and osteopenia should be considered as separate components of osteoporosis rather than as distinct diseases in themselves. This article will address the terminology used to describe osteoporosis and provide information aimed at educating health professionals about the definition of osteoporosis.

Anonymous Patient Answer

What are the signs of osteoporosis?

People who experience osteoporosis have signs and symptoms that include feeling tired and pain as well as low bone density. Symptoms that can occur in osteoporosis include: sudden onset pain, trouble walking, fractures, deformities, loss of muscle strength, bone pain and difficulty sleeping. Osteoporosis is a significant risk factor of fracture. It can be treated using osteoporosis drugs such as bisphosphonates.

Anonymous Patient Answer

Does prune improve quality of life for those with osteoporosis?

A 12-week self-managing intervention programme incorporating a prune product increased the level of adherence to a healthy diet, reduced waist circumference, and improved quality of life in women with osteoporosis. Prunes are an effective natural food that may be used to combat the effects of aging. More research is needed to unravel the full benefits of consuming prunes in combating the adverse health effects of the aging process.

Anonymous Patient Answer

Who should consider clinical trials for osteoporosis?

In the United States, trials evaluating a variety of drugs at any dose may be eligible for a drug manufacturer's accelerated approval program. In Canada, all osteoporosis drugs might be considered for clinical trial by the Food and Drug Administration, including investigational drugs that might not qualify for accelerated approvals.

Anonymous Patient Answer

Have there been any new discoveries for treating osteoporosis?

For many years little attention has been paid to the problem and it seemed that little attention could be given. We have done the homework to try and get to know how much we have to know prior to prescribing these drugs in our patients. All that needs to be done is let the patient know that we are trying, do not make a hasty decision to treatment, and be prepared to discuss any side effects or problems to come from long term use of these drugs.

Anonymous Patient Answer

Has prune proven to be more effective than a placebo?

Although the P prune extract had no effect on bone density, it had an unexpected effect on the urinary markers of bone resorption in all the study patients. Data from a recent study of this pilot study suggest that further clinical investigations are useful for determining the best regimen for the treatment of osteoporosis.

Anonymous Patient Answer

Is prune typically used in combination with any other treatments?

Recent findings suggest that the use of a prune-based regimen, such as Prolec, may reduce fracture risk more than any other regimen used with or without bone-altering medications. This is especially the case for patients who initiate therapy with an osteopenic bone mineral density of or less at the time of initiation.

Anonymous Patient Answer
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