ROLE OF ZOLEDRONIC ACID IN OSTEOPROTIC PATIENTS
- 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
- Registration Number
- CTRI/2016/10/007385
- Lead Sponsor
- s n medical college
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method student t score for fracture vertebra and hip - <br/ ><br>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 Outcome Measures
Name Time Method 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