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Effect of different hydration dose and infusion rate of zoledronic acid on renal safety in patients with primary osteoporosis: a randomized controlled study

Effect of different hydration dose and infusion rate of zoledronic acid on renal safety in patients with primary osteoporosis: a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061245
Enrollment
Unknown
Registered
2022-06-17
Start date
2021-01-11
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Osteoporosis

Interventions

Group 1 :250 mL 0.9% sodium chloride solution, 15minutes for zoledronic acid
Group 1 :250 mL 0.9% sodium chloride solution, 60 minutes for zoledronic acid
Group 3:1000 mL 0.9% sodium chloride solution, 15 minutes for zoledronic acid
Group 4:1000 mL 0.9% sodium chloride solution, 60 minutes for zoledronic acid

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of osteoporosis, that is, those who meet any of the following DXA measurements of lumbar spine 1-4 femoral neck total hip or distal radius 1/3 bone mineral density T value = 50 mL/min/1.73m2, blood Cr is within the normal reference range, and blood calcium is normal; 4. Patients voluntarily participate in this trial, and sign the consent form with informed consent to drug intervention and index measurement.

Exclusion criteria

Exclusion criteria: 1. People who are allergic to drug ingredients; 2. Combined with chronic kidney disease, diabetes, nephropathy, severe hypertension and other diseases that may affect renal function; 3. Those who have a recent history of taking nephrotoxic drugs such as aminoglycoside antibiotics, sulfonamides, and drugs containing aristolochic acid; 4. Patients clearly diagnosed as secondary OP.

Design outcomes

Primary

MeasureTime frame
Estimation of glomerular filtration rate;Serum creatinine;Blood urea nitrogen;Cysatin C;

Secondary

MeasureTime frame
Acute phase reaction;

Countries

China

Contacts

Public ContactDecai Chen

Department of Endocrinology, West China Hospital of Sichuan University

18980601309@163.com+86 18980601309

Outcome results

None listed

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