To compare the effect of preoperative use of Zoledronic acid versus placebo on postoperative bone health in patients with primary hyperparathyroidism
Phase 4
- Conditions
- Health Condition 1: E210- Primary hyperparathyroidism
- Registration Number
- CTRI/2019/10/021762
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with biochemically proven primary hyperparathyroidism fulfilling criteria to undergo surgery
Hypercalcemia ( Calcium levels > 11 mg/dL)
Exclusion Criteria
Renal dysfunction (Creatinine clearance <30 ml/minute)
Pregnancy or lactation.
Patients who have received any other bisphosphonates or antiresorptive therapy within a year before surgery.
Patients developing permanent hypoparathyroidism after surgery
Failed surgery
Any chronic disease that may affect bone health significantly.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone mineral density at 1 year <br/ ><br>Incidence of hungry bone syndromeTimepoint: 1 year
- Secondary Outcome Measures
Name Time Method Biochemical and bone turnover markers between the two groups <br/ ><br>Change in bone microarchitecture and remodelling rate between the two groups on bone biopsyTimepoint: 1 year