Perimenopausal Bone LossPrune-UPNCT07120997
Prunes Preventing Bone Loss in Perimenopause
A study testing Prunes, Calcium supplement and Vitamin D Supplement in people with Perimenopausal Bone Loss, run by Penn State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 44 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Bone Loss
- What is being tested?
- Prunes, Calcium supplement and Vitamin D Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Subjects 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
Show all 12Show fewer
- 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 strontium within the past 12 months; calcitonin; selective estrogen receptor modulators within the past 12 months; systemic oral or transdermal estrogen within the past 3 months; systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days); or tibolone within the past 3 months
- Hormonal contraception within the past three months
- Subjects who will not consume study provided dietary items or who will not stop taking their own natural product supplements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Women's Health and Exercise Laboratory, The Pennsylvania State University
University Park, Pennsylvania, 16802
Mary Jane De Souza, PhD, 814-863-0045, mjd34@psu.edu
Nancy I. Williams, ScD, 814-865-1346, niw1@psu.edu
About this study
Official title: A Prevention Strategy for the Indication of Prune Consumption in Perimenopausal Females: Can Prunes Attenuate Bone Loss?
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. The transmenopausal period represents an opportunistic window for the study because bone loss is at its greatest at this time, with females losing as much as 6-7% of bone. If this project is successful at attenuating bone loss, it can immediately be disseminated to the public to promote prune consumption to slow down and attenuate perimenopausal bone loss. As such, this project could improve the long-term bone health of females and avoid or delay osteoporosis and improve quality of life. The long-term goal of this study is to test the novel hypothesis that prune consumption for 18 months during the 3-year transmenopausal period prevents the dramatic rate of bone loss in perimenopausal females during a window of heightened physiological vulnerability. At Penn State University, the study will compare the effects of 18 months of daily dietary consumption of 50 g of prunes (5-6) versus a no-prune control group on bone outcomes (bone mineral density, bone geometry), mechanistic factors (bone and inflammatory markers, inflammatory response of ex vivo cultured peripheral blood mononuclear cells, monocytes), and gut microbiome.
Read the detailed description
Females spend at least one-third of their lifespan after menopause, therefore strategies that improve the long-term health of women and engage a prevention strategy to improve health are warranted and represent opportunities for high impact and high return on investment. After menopause, one in two females will suffer a fragility fracture in their lifetime, and the mortality rate after a hip fracture is as high as 25%. Moreover, since osteoporosis-related treatment costs more than $100 billion worldwide, strategies that focus on the prevention of osteoporosis-related fragility fractures are warranted. As such, the prevention of bone loss, osteoporosis, and its related fractures is much preferred over treatment of osteoporosis given the high costs, negative side effects, and poor compliance to pharmacological treatment regimens. Therefore, research addressing the optimization of the health of perimenopausal females to delay chronic disease is very much necessary and represents the overall objective of this project. Given the high mortality rate of hip fractures, this intervention may potentially save people's lives while reducing a significant healthcare burden.
The long-term goal of this project is to change the course of bone loss during a very specific and opportunistic intervention window, i.e., the transmenopausal window. This window of intervention is opportunistic because females lose more bone at the hip and spine than at any other time; that is, as much as 6% and 7% at the hip and spine, respectively. In fact, the amount of bone loss during this three-year transmenopausal window that initiates late perimenopause is greater than the amount of bone loss observed during the postmenopause window, when the latter is defined as 2 to 5 years after the final menstrual period. The STRAW+10 investigators defined the stages of menopause, including the transmenopause period, a stage in life that is associated with dramatic bone loss. As such, this project is novel, innovative, and can potentially delay the serious effects of osteoporotic bone loss and associated fractures, to which transmenopausal bone loss significantly contributes. When one considers that as of 2021, there were approximately 1.02 billion females over 50 years of age worldwide, with an estimated 1.2 billion females over the age of 50 by 2030, accounting for 26% of all females worldwide, the potential impact of this project is substantial. Indeed, this project may affect the long-term picture of bone health for millions of females by delaying or attenuating the acceleration of bone loss during the transmenopause period. Moreover, since osteoporosis affects millions of females worldwide, this project has the potential to offset the devasting long-term effects of accelerated bone loss during transmenopause that is associated with osteoporosis.
The overall objective of this research is to test whether prunes are effective in attenuating the rapid transmenopausal bone loss observed in late peri and early postmenopausal females. The investigators will study the effects of 18 months of prune consumption in females recruited during the late peri and early postmenopausal stage, allowing a high probability for data collection spanning the transmenopausal period of heightened bone loss, i.e., 12 months before the final menstrual period and the two years following the final menstrual period. The investigators will also examine the physiological mechanisms underlying the bone trophic effects of prune consumption to seek evidence on how prunes work. If successful, prunes will be demonstrated to be a powerful strategy to attenuate and delay the rapid decline in bone mineral density and decrements in microarchitecture that eventually lead to osteoporosis and heightened risk for fracture.
- Conditions
- Perimenopausal Bone Loss
- Being tested
- Prunes, Calcium supplement, Vitamin D Supplement
- Keywords
- Female, Transmenopause, Perimenopause, Perimenopausal Bone Loss, Menopause, Human, Osteoporosis, Non-pharmacologic therapy, Prune intake, Dried Plum
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrunesDietary supplement
Participants randomized to the 50g prune group will consume 6 prunes per day for the duration of the 18-month intervention.
Calcium supplementDietary supplement
All participants will consume calcium supplements daily for a baseline period and for the duration of the 18-month intervention.
Vitamin D SupplementDietary supplement
All participants will consume Vitamin D supplements daily for a baseline period and for the duration of the 18-month intervention.
| Study group | Role | What they receive |
|---|---|---|
| Calcium and Vitamin D - Control group | Experimental | Participants will take calcium and vitamin D supplements daily for a baseline period and for the duration of the intervention. Participants will be asked to refrain from consumption of prunes and fruits that have high phenolic content for the duration of the intervention (18 months). Receives: Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D Supplement |
| 50g Prunes, Calcium, and Vitamin D - Intervention Group | Experimental | Participants will take calcium and vitamin D supplements daily for a baseline period and for the duration of the intervention. Additionally, participants will be provided with prunes and asked to consume 6 (50g) prunes per day for the duration of the intervention (18 months). Receives: Dietary Supplement: Prunes; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck
Percent change in areal bone mineral density measured at baseline, month 9, and month 18 of the 18-week dietary intervention at the lumbar spine, total hip, and femoral neck.
Measured: Baseline, month 9, month 18
Secondary outcomes (11)
Changes from baseline in Spine Trabecular Bone Score (TBS) (via DXA)
Changes in Spine Trabecular Bone Score (TBS) assessed at baseline, month 9, and month 18 of the 18-month dietary intervention from lumbar spine DXA scans. The measurements will provide additional information about the effects of the intervention on trabecular bone.
Measured: Baseline, month 9, and month 18
Percent change from baseline in volumetric BMD of the tibia and radius (via pQCT)
Percent change in volumetric BMD, cortical and trabecular compartments, measured during baseline, month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.
Measured: Baseline, month 9, and month 18
Percent change from baseline in bone geometry measurements of the tibia and radius (via pQCT)
Percent change in bone geometry estimates (total bone area, cortical and trabecular area, cortical thickness) measured during baseline, and month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The combination of measurements will provide an overall picture of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.
Measured: Baseline, month 9, and month 18
Percent change from baseline in bone strength index of the tibia and radius (via pQCT)
Percent change in bone strength index (BSI) measured during baseline, and month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The measurement will provide an overall picture of bone strength and of the 3-dimensional structure of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.
Measured: Baseline, month 9, and month 18
Percent change from baseline in stress strain index of the tibia and radius (via pQCT)
Percent change in stress strain index (SSI), a bone strength measurement, measured during baseline, month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The measurements will provide an overall estimate of bone strength of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.
Measured: Baseline, Month 9, Month 18
Percent change from baseline in polar moment of inertia measurements of the tibia and radius (via pQCT)
Percent change in polar moment of inertia (section modulus) measured during baseline, and month 9, and month 18 of the 18-month dietary intervention at the tibia and radius. The measurement will provide an overall picture of the 3-dimensional structure and bone strength of a weight bearing (tibia) and non-weight bearing (radius) site and how the sites are impacted by the intervention.
Measured: Baseline, Month 9, Month 18
Change from baseline in C-terminal telopeptide of type I collagen (CTx)
Change in serially-sampled fasting serum concentrations of C-terminal telopeptide of type I collagen (CTx), a marker of bone resorption, at baseline, month 9, and month 18 of the 18-month dietary intervention. Changes in bone resorption markers will assist in understanding the underlying mechanisms behind changes in the rates of bone resorption.
Measured: Baseline, month 9, and month 18
Change from baseline in Tartrate-resistant acid phosphatase (Trap 5b)
Change in serially-sampled fasting serum concentrations of Tartrate-resistant acid phosphatase (Trap 5b), a marker of bone resorption, at baseline, month 9, and month 18 of the 18-month dietary intervention. Changes in bone resorption markers will assist in understanding the underlying mechanisms behind changes in the rates of bone resorption.
Measured: Baseline, month 9, and month 18
Change from baseline in expression of inflammatory markers
Change in lipopolysaccharide(LPS)-stimulated peripheral blood mononuclear cell (PBMC) gene expression of inflammatory markers (interleukin-1β, interleukin-6, and tumor necrosis factor-α) at baseline, month 9, and month 18 of the dietary intervention. Additionally, the relationship between the changes in gene expression of inflammation markers and bone outcomes will be explored. The combined changes of the gene expression of inflammatory markers will provide a comprehensive picture of the inflammatory environment of the participants before, during and following the dietary intervention. This comprehensive picture will assist in understanding the mechanisms by which the inflammatory environment contributes to bone loss in transmenopause and how the dietary intervention impacts those factors.
Measured: Baseline, month 9, and month 18
Change from baseline in gut permeability
Change in serially-sampled fasting serum concentrations of zonulin, a gut permeability marker, at baseline, month 9, and month 18 of the 18-month dietary intervention. Changes in zonulin will assist in understanding the underlying mechanisms of changes in the gut and bone metabolism.
Measured: Baseline, month 9, and month 18
Change from baseline in gut microbiome
Serially-sampled stool samples for assessment of changes in the Beta diversity of gut microbiome at baseline, month 9, and month 18 of the 18-month dietary intervention. Additionally, the relationship between the changes in the gut microbiome and bone outcomes will be explored.
Measured: Baseline, month 9, and month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start11 Dec 2025
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Georgia, California Dried Plum Board, United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Mary Jane DeSouza, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120997
- Sponsor's protocol ID
- STUDY00027323
- Other IDs
- 14223973
- Acronym
- Prune-UP
- Status last verified
- Feb 2026
- First submitted
- 31 Jul 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prevention Strategy for the Indication of Prune Consumption in Perimenopausal Females: Can Prunes Attenuate Bone Loss?
- ClinicalTrials.gov ID
- NCT07120997
- Acronym / sponsor ID
- Prune-UP / STUDY00027323
- Conditions
- Perimenopausal Bone Loss
- Keywords
- Female, Transmenopause, Perimenopause, Perimenopausal Bone Loss, Menopause, Human, Osteoporosis, Non-pharmacologic therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- University of Georgia, California Dried Plum Board, United States Department of Agriculture (USDA)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The transmenopausal period represents an opportunistic window for the study because bone loss is at its greatest at this time, with females losing as much as 6-7% of bone. If this project is successful at attenuating bone loss, it can immediately be disseminated to the public to promote prune consumption to slow down and attenuate perimenopausal bone loss. As such, this project could improve the long-term bone health of females and avoid or delay osteoporosis and improve quality of life. The long-term goal of this study is to test the novel hypothesis that prune consumption for 18 months during the 3-year transmenopausal period prevents the dramatic rate of bone loss in perimenopausal females during a window of heightened physiological vulnerability. At Penn State University, the study will compare the effects of 18 months of daily dietary consumption of 50 g of prunes (5-6) versus a no-prune control group on bone outcomes (bone mineral density, bone geometry), mechanistic factors (bone and inflammatory markers, inflammatory response of ex vivo cultured peripheral blood mononuclear cells, monocytes), and gut microbiome.
Detailed description
Females spend at least one-third of their lifespan after menopause, therefore strategies that improve the long-term health of women and engage a prevention strategy to improve health are warranted and represent opportunities for high impact and high return on investment. After menopause, one in two females will suffer a fragility fracture in their lifetime, and the mortality rate after a hip fracture is as high as 25%. Moreover, since osteoporosis-related treatment costs more than $100 billion worldwide, strategies that focus on the prevention of osteoporosis-related fragility fractures are warranted. As such, the prevention of bone loss, osteoporosis, and its related fractures is much preferred over treatment of osteoporosis given the high costs, negative side effects, and poor compliance to pharmacological treatment regimens. Therefore, research addressing the optimization of the health of perimenopausal females to delay chronic disease is very much necessary and represents the overall objective of this project. Given the high mortality rate of hip fractures, this intervention may potentially save people's lives while reducing a significant healthcare burden.
The long-term goal of this project is to change the course of bone loss during a very specific and opportunistic intervention window, i.e., the transmenopausal window. This window of intervention is opportunistic because females lose more bone at the hip and spine than at any other time; that is, as much as 6% and 7% at the hip and spine, respectively. In fact, the amount of bone loss during this three-year transmenopausal window that initiates late perimenopause is greater than the amount of bone loss observed during the postmenopause window, when the latter is defined as 2 to 5 years after the final menstrual period. The STRAW+10 investigators defined the stages of menopause, including the transmenopause period, a stage in life that is associated with dramatic bone loss. As such, this project is novel, innovative, and can potentially delay the serious effects of osteoporotic bone loss and associated fractures, to which transmenopausal bone loss significantly contributes. When one considers that as of 2021, there were approximately 1.02 billion females over 50 years of age worldwide, with an estimated 1.2 billion females over the age of 50 by 2030, accounting for 26% of all females worldwide, the potential impact of this project is substantial. Indeed, this project may affect the long-term picture of bone health for millions of females by delaying or attenuating the acceleration of bone loss during the transmenopause period. Moreover, since osteoporosis affects millions of females worldwide, this project has the potential to offset the devasting long-term effects of accelerated bone loss during transmenopause that is associated with osteoporosis.
The overall objective of this research is to test whether prunes are effective in attenuating the rapid transmenopausal bone loss observed in late peri and early postmenopausal females. The investigators will study the effects of 18 months of prune consumption in females recruited during the late peri and early postmenopausal stage, allowing a high probability for data collection spanning the transmenopausal period of heightened bone loss, i.e., 12 months before the final menstrual period and the two years following the final menstrual period. The investigators will also examine the physiological mechanisms underlying the bone trophic effects of prune consumption to seek evidence on how prunes work. If successful, prunes will be demonstrated to be a powerful strategy to attenuate and delay the rapid decline in bone mineral density and decrements in microarchitecture that eventually lead to osteoporosis and heightened risk for fracture.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium and Vitamin D - Control group | Experimental | Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D SupplementParticipants will take calcium and vitamin D supplements daily for a baseline period and for the duration of the intervention. Participants will be asked to refrain from consumption of prunes and fruits that have high phenolic content for the duration of the intervention (18 months). |
| 50g Prunes, Calcium, and Vitamin D - Intervention Group | Experimental | Dietary Supplement: Prunes, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D SupplementParticipants will take calcium and vitamin D supplements daily for a baseline period and for the duration of the intervention. Additionally, participants will be provided with prunes and asked to consume 6 (50g) prunes per day for the duration of the intervention (18 months). |
Who may qualify
- Ages
- 44 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- Subjects 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrunesParticipants randomized to the 50g prune group will consume 6 prunes per day for the duration of the 18-month intervention. | Dietary supplement | 50g Prunes, Calcium, and Vitamin D - Intervention Group |
| Calcium supplementAll participants will consume calcium supplements daily for a baseline period and for the duration of the 18-month intervention. | Dietary supplement | 50g Prunes, Calcium, and Vitamin D - Intervention Group, Calcium and Vitamin D - Control group |
| Vitamin D SupplementAll participants will consume Vitamin D supplements daily for a baseline period and for the duration of the 18-month intervention. | Dietary supplement | 50g Prunes, Calcium, and Vitamin D - Intervention Group, Calcium and Vitamin D - Control group |
Primary outcome
Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck
Time frame: Baseline, month 9, month 18
Percent change in areal bone mineral density measured at baseline, month 9, and month 18 of the 18-week dietary intervention at the lumbar spine, total hip, and femoral neck.
11 secondary outcomes
Changes from baseline in Spine Trabecular Bone Score (TBS) (via DXA)
Time frame: Baseline, month 9, and month 18
Percent change from baseline in volumetric BMD of the tibia and radius (via pQCT)
Time frame: Baseline, month 9, and month 18
Percent change from baseline in bone geometry measurements of the tibia and radius (via pQCT)
Time frame: Baseline, month 9, and month 18
Percent change from baseline in bone strength index of the tibia and radius (via pQCT)
Time frame: Baseline, month 9, and month 18
Percent change from baseline in stress strain index of the tibia and radius (via pQCT)
Time frame: Baseline, Month 9, Month 18
Percent change from baseline in polar moment of inertia measurements of the tibia and radius (via pQCT)
Time frame: Baseline, Month 9, Month 18
Change from baseline in C-terminal telopeptide of type I collagen (CTx)
Time frame: Baseline, month 9, and month 18
Change from baseline in Tartrate-resistant acid phosphatase (Trap 5b)
Time frame: Baseline, month 9, and month 18
Change from baseline in expression of inflammatory markers
Time frame: Baseline, month 9, and month 18
Change from baseline in gut permeability
Time frame: Baseline, month 9, and month 18
Change from baseline in gut microbiome
Time frame: Baseline, month 9, and month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prunes, Calcium supplement and Vitamin D Supplement in people with Perimenopausal Bone Loss, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Jane De Souza, PhD (814-863-0045, mjd34@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in areal bone mineral density (via DXA) of the lumbar spine, total hip, and femoral neck (time frame: Baseline, month 9, month 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.