postmenopausal osteopenia probiotics, osteopenia, postmenopausal women, serum turnover markers
Conditions
Interventions
Participants in multispecies probiotics group received oral form once daily for 6 months. The placebo group received the oral form with identical sachets as the probiotics once daily for 6 months. Par
Sponsors
Faculty of Medicine, Ramathibodi Hospital
Eligibility
Sex/Gender
Female
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in serum bone turnover markers 6 months serum CTX | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in serum bone turnover markers 6 months serum P1NP | — |
Countries
Thailand
Contacts
Public ContactOrawin Vallibhakara
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Outcome results
None listed