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Prunes for Bone Health

N/A
Recruiting
Led By Shirin Hooshmand, PhD
Research Sponsored by San Diego State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months, and 24 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if taking calcium and vitamin D supplements and/or eating prunes can help stop bone loss in women after menopause."

Who is the study for?
This trial is for postmenopausal women who have a bone mineral density (BMD) t-score between -0.5 and -2, indicating some loss of bone density but not severe osteoporosis. Participants should not be on hormone replacement therapy or other drugs affecting bone health for at least three months before the study starts.
What is being tested?
The study is testing whether prunes, in combination with calcium and vitamin D supplements, can help prevent further bone loss in postmenopausal women compared to just taking the supplements alone.
What are the potential side effects?
Prunes are generally safe but may cause digestive issues like bloating or gas due to their high fiber content. Overconsumption might lead to diarrhea or an upset stomach.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am postmenopausal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes from baseline in bone mineral density at 12 and 24 months
Secondary study objectives
Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months
Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 30 g prune/dayExperimental Treatment1 Intervention
Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.
Group II: Control (0 g prune/day)Active Control1 Intervention
Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.

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Who is running the clinical trial?

San Diego State UniversityLead Sponsor
170 Previous Clinical Trials
114,881 Total Patients Enrolled
Shirin Hooshmand, PhDPrincipal InvestigatorSan Diego State University
3 Previous Clinical Trials
115 Total Patients Enrolled
~133 spots leftby Dec 2028
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