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Alendronate sodium in the treatment of mineral and bone metabolic abnormalities in peritoneal dialysis patients: a multicenter randomized controlled study

Alendronate sodium in the treatment of mineral and bone metabolic abnormalities in peritoneal dialysis patients: a multicenter randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086604
Enrollment
Unknown
Registered
2024-07-08
Start date
2024-07-08
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CKD-MBD

Interventions

Experimental group:Alendronate sodium + calcitriol capsules
control group:calcitriol capsules

Sponsors

Xijing Hospital affiliated to Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Obtain written informed consent; 2. Age 18-80 years old; 3. Receiving maintenance peritoneal dialysis treatment for more than 6 months; 4. Meet the diagnostic criteria for CKD-MBD in the 2017 KDIGO Guidelines.

Exclusion criteria

Exclusion criteria: 1. Pre-treatment with bisphosphonates or other anti-bone resorption drugs in the past 6 months 2. Rule out hypodynamic bone disease according to biochemical indicators or bone biopsy; 3. History of parathyroidectomy; 4. History of hormone therapy in the past six months; 5. Severe malnutrition; 6. Active infection; 7. Complicated with serious heart, liver and lung diseases; 8. History of multiple myeloma or bone tumor; 9. Previous history of major upper digestive tract (GI) diseases, such as peptic ulcers and esophagus Inflammation or severe indigestion; 10. Plan to undergo invasive dental surgery during the study observation period; 11. The subject can stand or sit up for < 30 minutes; 12. Blood calcium < 2.1mmol/L; 13.PTH < 300pg/mL.

Design outcomes

Primary

MeasureTime frame
BMD;

Secondary

MeasureTime frame
BMD;bone metabolism indicators;The incidence of new fractures (non vertebral fractures and clinical vertebral fractures) within 18 months;

Countries

China

Contacts

Public ContactLijie He

Xijing Hospital affiliated to Air Force Medical University

43218204@qq.com+86 150 9118 5737

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026