Effects of zoledronic acid before parathyroid surgery in patients with primary hyperparathyroidism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is a randomized, double-blinded, placebo-controlled investigation assessing the impact of a single infusion of zoledronic acid on patients with primary hyperparathyroidism undergoing parathyroidectomy. The study aims to determine whether this treatment can improve bone health, cardiovascular parameters, and renal function one year after surgery. Primary outcomes include changes in bone mineral density at the lumbar spine, while secondary outcomes focus on various bone health and cardiovascular metrics. The trial seeks to clarify the role of bisphosphonates in optimizing post-surgical outcomes for these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aarhus University Hospital
  Aarhus N, Central Region of Denmark, Denmark Recruiting

Study contacts

• Principal investigator: Lars Rejnmark, Professor — Aarhus University Hospital
• Study coordinator: Anne Louise Vandsø Svenningsen, MD
• Email: ansvnn@rm.dk
• Phone: +45 60183895

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.