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ROLE OF ZOLEDRONIC ACID IN OSTEOPROTIC PATIENTS

TO STUDY THE ROLE OF ZOLEDRONIC ACID IN OSTEOPROTIC PATIENTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007385
Enrollment
200
Registered
2016-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- adult age between 50to 89 years with t score of -2.5 aur less with two mild vertebral fracture or one moderate vertebral fracture

Interventions

Intervention1: zoledronic acid: 5ml in 100 ml sline intravenous infusion for 30 min . Control Intervention1: placebo: 100 ml normal saline for 30 min by intravenous route

Sponsors

s n medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged between 50 to 89 years. 2. A bone mineral density T score of â??2.5 or less at the femoral neck, with or without evidence of existing vertebral fracture, or a T score of â??1.5 or less, with radiologic evidence of at least two mild vertebral fractures or one moderate vertebral fracture (Previous use of oral bisphosphonates was allowed, with the duration of the washout period dependent on previous use (e.g., previous use of >=48 weeks required 2 years of washout).

Exclusion criteria

Exclusion criteria: 1. Previous use of parathyroid hormone or sodium fluoride, 2. Use of anabolic steroids or growth hormone within 6 months before trial entry or oral or intravenous systemic corticosteroids within 12 months, and any previous use of strontium. 3. Patients with a serum calcium level of more than 2.75 mmol per liter or less than 2.00 mmol per liter were ineligible, as were patients with a calculated creatinine clearance of less than 30.0 ml per minute at either of two baseline visits or urine dipstick results of more than 2+ for protein, without evidence of contamination or bacteriuria.

Design outcomes

Primary

MeasureTime frame
student t score for fracture vertebra and hip - 3% in the zoledronic-acid group vs. 14% in the placebo group; relative risk, 0.21; 95% confidence interval [CI], 0.06 to 0.72, P value 0.01Timepoint: 1 year

Secondary

MeasureTime frame
vertebral fracture-2% in the zoledronic-acid group vs. 11% in the placebo group; relative risk, 0.18; 95% confidence interval [CI], 0.04 to 0.79, P value 0.02Timepoint: 1 year

Countries

India

Contacts

Public Contactchandra prakash pal

s n medical college,

drhussain03@gmail.com8126133300

Outcome results

None listed

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