Status:
ACTIVE_NOT_RECRUITING
OsteoPreP: Food Supplements for Postmenopausal Bone Health
Lead Sponsor:
Australian Catholic University
Collaborating Sponsors:
Pendulum Therapeutics
Curtin University
Conditions:
Postmenopausal Osteopenia
Bone Loss, Age Related
Eligibility:
FEMALE
40-65 years
Phase:
PHASE4
Brief 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 reso...
Detailed Description
It is well established that bone loss occurs throughout life after the attainment of peak bone mass which is usually reached by the end of the second decade of life. During the first 5-8 years followi...
Eligibility Criteria
Inclusion
- 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
- 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 last 3 years)
- Participation in other clinical intervention trials
- Antibiotics treatment 2 months prior to inclusion
- Unwilling to cease taking other probiotic or prebiotic supplements (current use)
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05348694
Start Date
May 1 2022
End Date
April 1 2025
Last Update
July 9 2024
Active Locations (1)
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1
Australian Catholic University
Melbourne, Victoria, Australia, 3000