OsteoPreP: Food Supplements for Postmenopausal Bone Health (NCT05348694) | Clinical Trial Compass
UnknownPhase 4
OsteoPreP: Food Supplements for Postmenopausal Bone Health
Australia160 participantsStarted 2022-05-01
Plain-language summary
To evaluate the effect of 12 months of supplementation with a probiotic (probiotic plus prebiotic; 2 capsules per day) on relative change (%) in total volumetric bone density (measured using high resolution peripheral quantitative computed tomography \[HR-pQCT\]) of the distal tibia.
Who can participate
Age range40 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Postmenopausal women, 40-65 years old
* Caucasian (due to significant differences in BMD and bone remodelling between ethnicities)
* At least one year since final menses
* Signed informed consent
* Up to date Covid 19 vaccination status
* Able to walk without the use of an aid
* Stated availability throughout the entire study period
* Mental capacity to understand and willingness to fulfil all the details of the protocol
* Residing in Melbourne, Victoria, Australia
Exclusion Criteria:
* Diagnosis of osteoporosis
* T-score of -2.5 or less at the femoral neck or lumbar spine (L1-L4) on the DXA scan at screening visit
* HbA1c ≥6.5% at screening visit
* Blood pressure at screening visit of systolic \>180 mmHg and/or diastolic \>120 mmHg
* Untreated hyperthyroidism
* Rheumatoid arthritis
* Diagnosed with a disease-causing secondary osteoporosis or malabsorption: chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, type 1/type 2 diabetes, or chronic liver disease
* Bariatric surgery
* Recently diagnosed malignancy (within the last 5 years)
* Current or recent oral corticosteroid use (any dose within the last 3 months, or 5mg of Prednisolone (or equivalent) or a higher daily dose for 14 days or more 3-12 months prior to screening)
* Use of antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, strontium ranelate (current or during the last 3 years)
* Use of teriparatide (current or during the la…
What they're measuring
1
Total volumetric bone mineral density of the distal tibia