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New treatment option for Perimenopausal Bone Loss
Official title Prunes Preventing Bone Loss in Perimenopause
ClinicalTrials.gov ID: NCT07120997
What this study is testing
- What it's testing
- Dietary interventions of prune consumption during the transmenopausal period are innovative methods to prevent bone loss. Modern medicine does not intervene to prevent or attenuate this highly vulnerable period of bone loss which, if successfully attenuated, can potentially prevent/delay osteoporosis in women.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 44 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- Age 44 to 55 years
- Not severely obese (BMI \<35 kg/m\^2)
- Healthy (determined by a screening questionnaire, physical and medical history by a certified nurse practitioner, complete metabolic panel, and...
- Willing to include prunes in their daily diet
- Not taking any natural dietary supplement containing phenolics, i.e.,\< 1 cup/day of blueberries or apples for at least 2 months prior to study entry
You likely can't join if
- people who regularly consume prunes, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day)
- History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 45 yr)
- Untreated hyper- or hypothyroidism
- Current hyper- or hypoparathyroidism
- Significantly impaired renal function
- Current hypo- or hypercalcemia
See the full eligibility criteria
- Age 44 to 55 years
- Not severely obese (BMI \<35 kg/m\^2)
- Healthy (determined by a screening questionnaire, physical and medical history by a certified nurse practitioner, complete metabolic panel, and complete blood count)
- Willing to include prunes in their daily diet
- Not taking any natural dietary supplement containing phenolics, i.e.,\< 1 cup/day of blueberries or apples for at least 2 months prior to study entry
- Non-smoking
- Ambulatory
- No menses for ≥60 days but not more than 18 months post final menstrual period
- Only participants who have a determinable natural (not surgical) final menstrual period date are eligible
- people who regularly consume prunes, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day)
- History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 45 yr)
- Untreated hyper- or hypothyroidism
- Current hyper- or hypoparathyroidism
- Significantly impaired renal function
- Current hypo- or hypercalcemia
- History of spinal stenosis
- History of heart attack, stroke, thromboembolism, kidney disease, malabsorption syndrome, or seizure disorders
- Positive for HIV, Hep-C or Hep-B surface antigen and malignancy
- Use of the following agents affecting bone metabolism: intravenous bisphosphonates at any time; fluoride (for osteoporosis) within the past 24 months; denosumab at any time; bisphosphonates, parathyroid hormone or...
- Hormonal contraception within the past three months
- people who will not consume study provided dietary items or who will not stop taking their own natural product supplements
The study team makes the final eligibility decision.
Where it's taking place
- University Park, Pennsylvania, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 44 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include University Park, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.