Osteoporosis
Conditions
Interventions
Probiotic Intervention Group:Receive Bifidobacterium strains (probiotic solid beverage, 2g/day, viable count >10^9 CFU/g) combined with calcium and calcitriol.
Placebo Control Group:Receive maltodextrin (2g/day, placebo) combined with calcium and calcitriol.
Sponsors
The People's Hospital of Baoan Shenzhen
Eligibility
Sex/Gender
Female
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women with a DXA T-score between -2.5 and -1.0 and a 10-year hip fracture risk >=7% as assessed by the FRAX® model, or a T-score =2 years and =2 years); 3. Willing to take oral probiotic preparations and able to provide written informed consent; 4. Able and willing to comply with study visits and protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Diseases affecting bone metabolism (e.g., hyperthyroidism, Cushing’s syndrome, osteogenesis imperfecta, severe hepatic or renal dysfunction); 2. Use of antiresorptive or bone-active medications within the past 6 months (e.g., bisphosphonates, PTH); 3. Active malignancy; 4. History of fragility fractures or requiring long-term bed rest; 5. Chronic gastrointestinal disorders or malabsorption syndromes; 6. Recent or planned use of antibiotics; 7. Participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Mineral Density; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Gla Protein (BGP, also known as Osteocalcin);Procollagen Type I N-Terminal Propeptide;C-terminal Telopeptide of Type I Collagen;Serum calcium;Phosphorus; | — |
Countries
China
Contacts
Public ContactPan Xiaohua
The People's Hospital of Baoan Shenzhen
Outcome results
None listed