Effects of Multispecies Probiotic Supplementation on Serum Bone Turnover Markers in Postmenopausal Women with Osteopenia: A Randomized, Double-Blind, Placebo-Controlled Trial
- Conditions
- probiotics, osteopenia, postmenopausal women, serum turnover markerspostmenopausal osteopenia
- Registration Number
- TCTR20230326002
- Lead Sponsor
- Faculty of Medicine, Ramathibodi Hospital
- Brief Summary
Our study has demonstrated that multispecies probiotic supplementation for 12 weeks in osteopenic postmenopausal women may retard the increase in serum bone resorption marker CTX by downregulating osteoclast-induced bone resorption without significant adverse effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 40
Postmenopausal who are amenorrheic for at least 12 months with serum FSH greater than or equal to 40 IU/L or post bilateral oophorectomy, aged 45-70 years, diagnosed with osteopenia using BMD measurement by dual energy X-ray absorptiometry (DXA) with T-score between -1 and -2.5 at lumbar spine, total hip or femoral neck. These patients are supplemented with calcium 1,200 mg/d and Vitamin D2 20,000 Units per week and are asked to avoid food high in probiotics content with a limit of no more than once a week (i.e. milk, yoghurt, cheese, kimchi). All patients need to write and sign a written informed consent.
Diagnosed with osteoporosis (BMD from DEXA scan T-score less than or equal to -2.5) at lumbar spine, total hip or femoral neck, history of fragility fracture, BMI <18 or > 35 kg/m2, have secondary causes of bone loss screened from history and physical examination such as
Metabolic bone disease or other chronic diseases such as renal or liver diseases, ischemic disease, diabetes mellitus, cancer, thyroid or parathyroid diseases, Vitamin D deficiency with serum 25(OH) vitamin D < 20 ng/ml, autoimmune diseases on immunosuppressants, GI diseases and eating disorders such as malabsorptive disorders, anorexia nervosa, bulimia nervosa, inflammatory bowel disease, or currently using drugs altering bone metabolism such as bisphosphonates, raloxifene, calcitonin, anabolic agent, growth hormone, parathyroid hormone, steroids, anticoagulant within past 3 months, history of using probiotics or supplements altering bone metabolism within 3 months. Patients who cannot give a written informed consent are excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in serum bone turnover markers 6 months serum CTX
- Secondary Outcome Measures
Name Time Method changes in serum bone turnover markers 6 months serum P1NP