Chronic kidney disease (CKD) Urological and Genital Diseases
Conditions
Interventions
128 elderly patients (=65 years) with CKD stage 2–3 and osteoporosis were randomly assigned to receive either alendronate sodium/vitamin D3 plus B. lactis BB-12 (intervention group, n = 64) or alendro
Bifidobacterium lactis BB-12 1×10¹° CFU/day
Elemental calcium 500 mg/day (as calcium carbonate)
Administration method: alendronate sodium/vitamin D3 tablets taken in the morning on an empty stomach with a full glass of water
B. lactis BB-12 capsules taken in the evening with cold or lukewarm drinks
calcium carbonate taken as routine
Frequency: alendronate sodium/vitamin D3 once weekly
B. lactis BB-12 and calcium carbonate once daily
Control group (n = 64):
Dosage: alendronate sodium 70 mg + vitamin D3 2800 IU/week
placebo capsules (containing maltodextrin) one capsule/day
elemental calcium 500 mg/day (as calcium carbonate)
Administration method: alendronate sodium/vitamin D3 tablets taken as the intervention group
placebo capsules taken in the evening with cold or lukewarm drinks
placebo and calcium carbonate once daily
Total treatment time: 12 months
Follow-up duration: 12 months (key timepoints: baseline, 3 months, 6 months, 12 months)
Randomization process:
Randomization r
Sponsors
First Affiliated Hospital of Xinxiang Medical College
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =65 years 2. Confirmed CKD stage 2–3 [estimated glomerular filtration rate [eGFR] = 36-59 mL/min/1.73m² consistently exceeds for more than three months (stage 3); GFR = 60-89 mL/min/1.73m², accompanied by other kidney abnormalities for more than three months (stage 2) calculated using the CKD-EPI equation], with all enrolled patients having eGFR =35 mL/min/1.73m²at baseline to align with drug safety guidelines for alendronate use 3. Diagnosis of osteoporosis according to WHO criteria (T-score =-2.5 at lumbar spine or femoral neck, or presence of fragility fracture) 4. Stable renal function (eGFR change <5 mL/min/1.73m² in the preceding 3 months) 5. Ability to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. History of gastrointestinal disorders affecting absorption (e.g., inflammatory bowel disease, celiac disease) 2. Use of antibiotics, probiotics, or synbiotics within 3 months prior to enrollment 3. Current use of medications affecting bone metabolism other than vitamin D and calcium (e.g., glucocorticoids, hormone replacement therapy, denosumab, teriparatide) 4. Contraindications to bisphosphonate therapy (e.g., esophageal abnormalities, inability to remain upright for 30 minutes) 5. Secondary causes of osteoporosis other than CKD (e.g., hyperthyroidism, hyperparathyroidism) 6. History of malignancy within 5 years 7. Active infection or inflammatory disease 8. Life expectancy <12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Lumbar spine (L1-L4) bone mineral density (BMD) percentage change is measured using dual-energy X-ray absorptiometry (DXA, Lunar Prodigy, GE Healthcare) at baseline and 12 months 2. Femoral neck BMD percentage change is measured using dual-energy X-ray absorptiometry (DXA, Lunar Prodigy, GE Healthcare) at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum levels of bone turnover markers (C-terminal telopeptide of type I collagen [CTX-I] and procollagen type I N-terminal propeptide [P1NP]) are measured using electrochemiluminescence immunoassays (Roche Diagnostics) at baseline, 3 months, 6 months and 12 months. 2. Serum levels of mineral metabolism parameters (calcium, phosphate, intact parathyroid hormone [iPTH], 25-hydroxyvitamin D [25(OH)D] and fibroblast growth factor 23 [FGF23]) are measured using laboratory routine tests at baseline, 6 months and 12 months. 3. T cell subsets (Th1, Th2, Th17 and regulatory T cell [Treg]) are measured using flow cytometry (BD FACSCanto II) with fluorochrome-conjugated antibodies (CD3, CD4, CD8, CD25, FOXP3, IFN-?, IL-4 and IL-17A) at baseline and 12 months. 4. T cell metabolic parameters (oxygen consumption rate [OCR], extracellular acidification rate [ECAR], OCR/ECAR ratio and spare respiratory capacity) are measured using a Seahorse XFe96 Extracellular Flux Analyzer (Agilent Technologies) with mitochondrial and glycolysis stress tests at baseline and 12 months. 5. Serum levels of inflammatory markers (pro-inflammatory cytokines IL-6, IL-17, TNF-a and anti-inflammatory cytokines IL-10, TGF-ß) are measured using multiplex immunoassays at baseline and 12 months. 6. Gut microbiota composition (diversity and genus relative abundance) is measured using 16S rRNA gene sequencing (Illumina MiSeq platform) with QIIME2 software analysis at baseline and 12 months. 7. Kidney function parameters (estimated glomerular filtration rate [eGFR] and urinary albumin-to-creatinine ratio [UACR]) are measured using laboratory routine tests at baseline, 3 months, 6 months and 12 months. 8. Adverse events are recorded throughout the study period, and laboratory parameters for safety assessment (complete blood count, liver function tests and renal function tests) are measured using laboratory routine tests at baseline, 3 months, 6 months and 12 months. 9. Bifidobacterium lactis BB-12 colo | — |
Countries
China
Contacts
Public ContactYun Liu
Outcome results
None listed