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Bone protective effect of alendronate sodium in patients with stage CKD1-3 treated with glucocorticoids: a multicenter randomized controlled study

Bone protective effect of alendronate sodium in patients with stage CKD1-3 treated with glucocorticoids: a multicenter randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085924
Enrollment
Unknown
Registered
2024-06-21
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

CKD1-3 stage

Interventions

Test group:Alendronate sodium + calcium carbonate D3+ calcitriol capsules
Control group:calcium carbonate D3+ 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. Meet the staging standards of KDOQI guidelines for CKD1-3 stages; 4. Receiving glucocorticoid treatment for >6 months, prednisone dose >7.5mg/d or taking other hormones of equivalent price;

Exclusion criteria

Exclusion criteria: 1. Received anti-bone resorption drugs in the last 6 months; 2. History of primary hyperparathyroidism, hyperthyroidism, hypothyroidism, or parathyroidectomy; 3. severe malnutrition; 4. Active infection; 5. Serious lesions of heart, liver, lung and other vital organs; 6. History of multiple myeloma or bone tumor; 7. Allergy to alendronate sodium; 8. Pregnant and lactating women; 9. Previous history of major upper digestive tract (GI) disease, such as peptic ulcer, esophagitis, or severe dyspepsia; 10. Inability to stand or sit upright for more than 30 minutes; 11. Relevant biochemical indicators or bone biopsies suggest low-transport bone disease.

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