Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism

Condition(s) studied

Investigational drug(s) / intervention(s)

Zoledronic acid 4 mg: Product name/EU MP number: Zoledronic Acid Oresund Pharma 4 mg/100 ml infusionsvätska, lösning/PRD8924813 (Test) Substance (name/ code): ZOLEDRONIC ACID/SUB00176MIG Strength: Zoledronic Acid 0.04mg Pharmaceutical form: SOLUTION FOR INFUSION Route of administration: INFUSIÓN INTRAVENOSA Marketing authorisation status (MA number, MS where authorised etc): 52486 / SE Modified in relation to MA: No Max Dosage: mg milligram(s) Duration of use: Week

Natriumklorid 9 mg/ml, Fresenius Kabi: Product name/EU MP number: Natriumklorid "Baxter" ClearFlex 9 mg/ml,infusionsvæske, opløsning/PRD456031 (Placebo) Substance (name/ code): SODIUM CHLORIDE/SUB12581MIG Strength: Sodium Chloride 0.9g / 100mL Pharmaceutical form: SOLUTION FOR INFUSION Route of administration: INFUSIÓN INTRAVENOSA Marketing authorisation status (MA number, MS where authorised etc): 32466 / DK Modified in relation to MA: No Max Dosage: ml millilitre(s) Duration of use: Week

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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. — 12 months (one year)
  aBMD (g/cm\^3) will be measured by DXA-scans at baseline and one year after PTX.

Trial sites (1)

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