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Taking peoplePhase 4

Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism

Key facts

Who runs it
University of Aarhus
Where
Denmark1 site in 1 countryChoose a country to see its sites
Status
Recruiting
Phase
Phase 4
People taking part
140 people, planned
Started
1 Mar 2025
Expected to end
1 Feb 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Zoledronic acid 4 mg
  • Natriumklorid 9 mg/ml, Fresenius Kabi
Record updated
1 October 2026

Who can take part

Age
40 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Females or males > 40 years
  • A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX
  • aBMD T-score or Z-score ≤ -1 at total hip, femoral neck, distal forearm, or lumbar spine
  • 25-hydroxyvitamin D ≥ 50 nmol/l prior to randomization
  • Willingness to undergo PTX

Who cannot take part

  • 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
  • Known allergy to bisphosphonates
  • Known or suspected familial ethology (e.g., MEN1 or 2)
  • Estimated glomerular filtration rate < 35 ml/min

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Zoledronic acidExisting treatment, for comparison

    Patients referred to Aarhus University Hospital (AUH) for PTX due to PHPT will be included prospectively. We aim to include 140 patients with PHPT - 70 patients in each group. Patients will be enrolled consecutively until the required number of participants have been achieved. Enrolled participants will be randomized to intervention (active medicine) or placebo group and receive either zoledronate or placebo (saline water) 2-4 weeks prior to PTX.

    Treatment: Zoledronic acid 4 mg

  • PlaceboPlacebo, for comparison

    Patients referred to Aarhus University Hospital (AUH) for PTX due to PHPT will be included prospectively. We aim to include 140 patients with PHPT - 70 patients in each group. Patients will be enrolled consecutively until the required number of participants have been achieved. Enrolled participants will be randomized to intervention (active medicine) or placebo group and receive either zoledronate or placebo (saline water) 2-4 weeks prior to PTX.

    Treatment: Natriumklorid 9 mg/ml, Fresenius Kabi

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Bisphosphonate vs. Placebo Prior to Parathyroidectomy in Primary Hyperparathyroidisme: A Randomized, Double-blinded Placebo-controlled Trial
Record updated
1 October 2026