Effects of zoledronic acid before parathyroid surgery in patients with primary hyperparathyroidism
Bisphosphonate vs. Placebo Prior to Parathyroidectomy in Primary Hyperparathyroidisme: A Randomized, Double-blinded Placebo-controlled Trial
This study tests if giving a single dose of zoledronic acid before parathyroid surgery can help improve bone health and overall well-being for people with primary hyperparathyroidism.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Aarhus N, Central Region of Denmark) |
| Trial ID | NCT06859580 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal females or males over 50 years with a diagnosis of primary hyperparathyroidism and low bone mineral density.
Not a fit: Patients with known familial causes of hyperparathyroidism or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance post-surgical recovery and long-term health outcomes for patients with primary hyperparathyroidism.
How similar studies have performed: While the use of bisphosphonates in this context is being explored, the specific approach of this study is novel and has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus N, Central Region of Denmark
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.