Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism

Launched by UNIVERSITY OF AARHUS · Feb 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called zoledronic acid (ZOL) on people with primary hyperparathyroidism (PHPT) who are preparing for a surgery called parathyroidectomy (PTX). PHPT is a condition that causes high calcium levels in the blood, which can lead to weakened bones and other health issues. The trial aims to find out if giving ZOL a few weeks before surgery can help improve bone health, heart health, and kidney function a year after the surgery. Participants will be randomly assigned to receive either ZOL or a placebo (a substance with no active medication) before their surgery, and their bone density and overall health will be monitored.

To be eligible for this trial, participants must be postmenopausal women or men over 50 years old with low bone density and a diagnosis of PHPT. They must also be willing to undergo the surgery. However, those with certain conditions, allergies to bisphosphonates, or specific recent medical treatments will not be included. Throughout the study, participants can expect various health assessments, including imaging and blood tests, to track their progress. This research could help improve treatment strategies for individuals with PHPT and enhance their long-term health outcomes.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Postmenopausal females or males \> 50 years
• • 2. A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX
• • 3. aBMD T-score ≤ -1 at total hip, femoral neck, or lumbar spine
• • 4. 25-hydroxyvitamin D ≥ 50 nmol/l prior to randomization
• • 5. Willingness to undergo PTX
• Exclusion Criteria:
• • 1. Known or suspected familial ethology (e.g., MEN1 or 2)
• • 2. Estimated glomerular filtration rate \< 35 ml/min
• • 3. Known allergy to bisphosphonates
• • 4. Planned or recent (within the last 3 months) major dental procedures (e.g., jaw surgery or tooth extraction)
• • 5. 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.