Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Primary Hyperparathyroidism
In brief
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 and low BMD will be enrolled and randomized to receive either ZOL or placebo 2-4 weeks before PTX. Participants will undergo extensive imaging, biochemical analysis, and cardiovascular assessments at baseline and one year post-surgery. This study seeks to clarify whether ZOL improves post-surgical bone recovery or interferes with the natural bone remodeling process following PTX. Additionally, it will provide insight into the cardiovascular and renal effects of bisphosphonate therapy in PHPT patients. Findings may help guide treatment strategies for optimizing long-term skeletal and systemic health in this patient population.
Key facts
- Study ID
- NCT06859580
- Run by
- University of Aarhus
- People needed
- 140
- Starts
- 2025-03-01
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2025-03-25
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Postmenopausal females or males > 50 years
- A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX
- aBMD T-score ≤ -1 at total hip, femoral neck, or lumbar spine
- 25-hydroxyvitamin D ≥ 50 nmol/l prior to randomization
- Willingness to undergo PTX
You may not qualify if…
- Known or suspected familial ethology (e.g., MEN1 or 2)
- Estimated glomerular filtration rate < 35 ml/min
- Known allergy to bisphosphonates
- Planned or recent (within the last 3 months) major dental procedures (e.g., jaw surgery or tooth extraction)
- Chronic or acute disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, cancer) or prior medications (e.g., lithium, glucocorticoids within the last year, antiresorptive or bone anabolic treatment within the last 3 years) known to affect bone metabolism.
Where it is running
- Aarhus University Hospital — Aarhus N, Central Region of Denmark, Denmark (enrolling)
Full record on ClinicalTrials.gov
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