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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week 12, week 24, week 36, and week 52
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can walk on my own without help.
Select...
I am a woman who has gone through menopause.
Select...
My bone density test shows I have low bone mass.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone and Bones
Secondary outcome measures
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 moreOther outcome measures
Change from baseline in cellular bone metabolism
Change from baseline in expression of inflammatory markers
Change from baseline in gut microbiome
+2 moreSide effects data
From 2014 Phase 3 trial • 645 Patients • NCT0007900162%
Fatigue
54%
Myalgia
25%
Creatinine increased
23%
Nausea
20%
Diarrhea
19%
Serum calcium decreased
17%
Anorexia
14%
Serum potassium decreased
14%
Fever
13%
Vomiting
12%
Chills
12%
Rash desquamating
12%
Serum phosphate decreased
7%
Serum magnesium decreased
7%
Pruritus
6%
Bone pain
5%
Back pain
5%
Alkaline phosphatase increased
4%
Blood glucose increased
3%
Erectile dysfunction
3%
Hypersensitivity
3%
Hemoglobin decreased
3%
Osteonecrosis
2%
Insomnia
2%
Urinary retention
2%
Leukocyte count decreased
2%
Myocardial ischemia
2%
Constipation
2%
Serum sodium decreased
2%
Arthralgia
2%
Dyspnea
2%
Renal failure
1%
Disease progression
1%
Infection
1%
Serum albumin decreased
1%
Bladder infection
1%
Laboratory test abnormal
1%
Pneumonia
1%
Ureteric obstruction
1%
Dehydration
1%
Peripheral motor neuropathy
1%
Musculoskeletal disorder
1%
Skin infection
1%
Pain
1%
Muscle weakness
1%
Alanine aminotransferase increased
1%
Cardiac disorder
1%
Abdominal pain
1%
Lower gastrointestinal hemorrhage
1%
Small intestinal obstruction
1%
Sudden death
1%
Urinary tract infection
1%
Fracture
1%
Lymphocyte count decreased
1%
Neutrophil count decreased
1%
Dizziness
1%
Syncope vasovagal
1%
Hemolysis
1%
Cataract
1%
Pain in extremity
1%
Treatment related secondary malignancy
1%
Dysgeusia
1%
Headache
1%
Urinary frequency
1%
Testicular pain
1%
Cough
1%
Hot flashes
1%
Hypertension
1%
Serum magnesium increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zoledronic Acid + Androgen Deprivation Therapy
Placebo + Androgen Deprivation Therapy
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
Vitamin D supplement
2020
Completed Phase 3
~1220
Find a Location
Who is running the clinical trial?
Penn State UniversityLead Sponsor
355 Previous Clinical Trials
125,435 Total Patients Enrolled
California Dried Plum BoardOTHER
2 Previous Clinical Trials
55 Total Patients Enrolled
Mary Jane De Souza, PhDPrincipal InvestigatorThe Pennsylvania State University
3 Previous Clinical Trials
466 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart, blood clot, kidney issues, malabsorption, or seizures.I can walk on my own without help.I am a woman who has gone through menopause.I have had a bone fracture after age 50.Women who eat a lot of dried plums, dried apples, prune juice, or blueberries (1 cup or more/day) need to stop eating these foods for at least 2 months before joining the study.My parathyroid gland is overactive or underactive.I am HIV positive or have Hepatitis B/C and cancer.I haven't used specific bone treatments or steroids recently.I will not take any supplements not approved by the study.I haven't taken supplements with phenolics, blueberries, or apples for 2 months.My bone density test shows I have low bone mass.You have low or high levels of calcium in your blood right now.My kidneys do not work well and I have high potassium levels.Your vitamin D levels are too low (less than 20 ng/mL).I have been diagnosed with spinal stenosis.You are not extremely overweight (BMI less than 40 kg/m2).You are in good health based on a screening questionnaire and blood test.I have untreated thyroid issues.
Research Study Groups:
This trial has the following groups:- Group 1: 100g Dried Plums
- Group 2: Ca2+/VitD Control
- Group 3: 50g Dried Plums
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Does the criteria for this trial have an age restriction below fifty?
"Eligibility for this trial is limited to individuals aged between 55 and 75."
Answered by AI
Are there still opportunities to join this investigation?
"According to the information found on clinicaltrials.gov, recruitment for this trial is not currently ongoing. It was first posted in June 2016 and last edited in September 2022; however, there are 138 other trials that are actively recruiting at present."
Answered by AI
Am I eligible to take part in this experiment?
"This clinical trial seeks to recruit 322 post-menopausal women aged 55 to 75 who have osteoporosis. Candidates must not be too overweight (BMI < 40 kg/m2), abstain from taking any natural dietary supplements with phenolics, blueberries or apples for two months before the study commences and remain non-smokers. Furthermore, they need to show low bone mineral density as measured by dual energy X-ray absorptiometry (DXA) with T scores between 0 and -3.0 that can include lumbar spine, total hip and femoral neck measurements. Lastly these future participants are"
Answered by AI
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