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Dried Plums for Osteoporosis

N/A

Waitlist Available

Led By Mary Jane De Souza, PhD

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ambulatory

Postmenopausal women

Must not have

History of heart attack, stroke, thromboembolism, kidney disease, malabsorption syndrome, seizure disorders

History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 50 yr

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, week 12, week 24, week 36, and week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether dried plums can help improve bone health in postmenopausal women, and how much dried plum needs to be consumed for this benefit. The trial will also look at how dried plums might impact bone health by measuring different markers in the women's urine.

Who is the study for?

This trial is for postmenopausal women with low bone mineral density but not severe obesity or significant health issues like heart disease, kidney problems, or untreated thyroid conditions. Participants should be non-smokers, able to walk, and willing to eat dried plums daily without taking other natural dietary supplements.

What is being tested?

The study tests the effects of eating different amounts of dried plums for a year on bone strength in postmenopausal women. It will measure changes in bone density and investigate how compounds from the plums might affect bone metabolism.

What are the potential side effects?

While specific side effects are not listed, potential concerns may include digestive changes due to high fiber content in dried plums. As with any dietary change, individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk on my own without help.

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I am a woman who has gone through menopause.

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My bone density test shows I have low bone mass.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart, blood clot, kidney issues, malabsorption, or seizures.

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I have had a bone fracture after age 50.

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My parathyroid gland is overactive or underactive.

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I am HIV positive or have Hepatitis B/C and cancer.

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I will not take any supplements not approved by the study.

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My kidneys do not work well and I have high potassium levels.

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I have been diagnosed with spinal stenosis.

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I have untreated thyroid issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, week 12, week 24, week 36, and week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, week 12, week 24, week 36, and week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 12, week 24, week 36, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bone and Bones

Secondary study objectives

Change from baseline in bone turnover markers

Percent change from baseline in DXA hip structural analysis

Percent change from baseline in DXA spine trabecular bone score

+3 more

Other study objectives

Change from baseline in cellular bone metabolism

Change from baseline in expression of inflammatory markers

Change from baseline in gut microbiome

+2 more

Side effects data

From 2014 Phase 3 trial • 645 Patients • NCT00079001

62%

Fatigue

54%

Myalgia

25%

Creatinine increased

23%

Nausea

20%

Diarrhea

19%

Serum calcium decreased

17%

Anorexia

14%

Fever

14%

Serum potassium decreased

13%

Vomiting

12%

Chills

12%

Serum phosphate decreased

12%

Rash desquamating

Serum magnesium decreased

Pruritus

Bone pain

Alkaline phosphatase increased

Back pain

Blood glucose increased

Hemoglobin decreased

Hypersensitivity

Osteonecrosis

Erectile dysfunction

Dyspnea

Urinary retention

Myocardial ischemia

Renal failure

Constipation

Leukocyte count decreased

Serum sodium decreased

Arthralgia

Insomnia

Testicular pain

Cough

Pain in extremity

Treatment related secondary malignancy

Cardiac disorder

Small intestinal obstruction

Abdominal pain

Lower gastrointestinal hemorrhage

Disease progression

Pain

Bladder infection

Sudden death

Fracture

Urinary tract infection

Laboratory test abnormal

Lymphocyte count decreased

Neutrophil count decreased

Dehydration

Muscle weakness

Musculoskeletal disorder

Dizziness

Syncope vasovagal

Peripheral motor neuropathy

Ureteric obstruction

Hypertension

Hemolysis

Cataract

Infection

Pneumonia

Skin infection

Alanine aminotransferase increased

Serum albumin decreased

Serum magnesium increased

Dysgeusia

Headache

Urinary frequency

Hot flashes

100%

80%

60%

40%

20%

Study treatment Arm

Zoledronic Acid + Androgen Deprivation Therapy

Placebo + Androgen Deprivation Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Ca2+/VitD ControlExperimental Treatment2 Interventions

Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Participants will be asked to refrain from consumption of dried plums for the duration of the intervention (52 weeks).

Group II: 50g Dried PlumsExperimental Treatment3 Interventions

Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 6 (50g) dried plums per day for the duration of the intervention (52 weeks).

Group III: 100g Dried PlumsExperimental Treatment3 Interventions

Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 12 (100g) dried plums per day for the duration of the intervention (52 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dried Plum

2017

N/A

~110

Calcium supplement

2018

Completed Phase 3

~2100