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Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism

RecruitingPhase 4Ages 40 Years - anyAllUniversity of Aarhus
NCT06859580 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Females or males \> 40 years 2. A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX 3. aBMD T-score or Z-score ≤ -1 at total hip, femoral neck, distal forearm, 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.
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What it tests

  • Zoledronic acid 4 mg
  • Natriumklorid 9 mg/ml, Fresenius Kabi
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Where

1 site
Aarhus University Hospital
Aarhus N, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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