Phase 4Recruiting
Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism (ZOLPHPT)
Bisphosphonate vs. Placebo Prior to Parathyroidectomy in Primary Hyperparathyroidisme: A Randomized, Double-blinded Placebo-controlled Trial
- Sponsor
- University of Aarhus (Academic or other)
- Enrolment
- 140 planned
- Conditions
- Primary Hyperparathyroidism
- Interventions
- Zoledronic acid 4 mg; Natriumklorid 9 mg/ml, Fresenius Kabi
- Ages
- adults, older adults
- Registry
- NCT06859580
From the registry
This study is a randomized, double-blinded, placebo-controlled trial investigating the effects of zoledronic acid (ZOL) versus placebo in patients with primary hyperparathyroidism (PHPT) undergoing parathyroidectomy (PTX). PHPT is a common endocrine disorder associated with hypercalcemia, reduced bone mineral density (BMD), increased fracture risk, renal calcifications, and cardiovascular complications. While PTX remains the definitive treatment, the potential role of bisphosphonates in optimizing post-surgical outcomes remains unclear. This trial aims to evaluate whether a single infusion of ZOL prior to PTX impacts bone health, cardiovascular parameters, and renal function one year post-surgery. The primary endpoint is the change in areal bone mineral density (aBMD) at the lumbar spine one year after PTX. Secondary endpoints include changes in aBMD at other skeletal sites, volumetric BMD, bone microarchitecture, bone turnover markers, coronary artery calcium score, arterial stiffness, and renal calcifications. A total of 140 postmenopausal women and men over 50 years with PHPT…
Primary outcomes
- Effects of ZOL vs. placebo at time of parathyroidectomy based on change in aBMD at lumbar spine meased at baseline compared to one year after PTX.