Status:
RECRUITING
Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
Lead Sponsor:
University of Aarhus
Conditions:
Primary Hyperparathyroidism
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 pa...
Detailed Description
Aim The overall aim of this study is a physiological investigation of the effect of bisphosphonate treatment versus placebo at time of parathyroidectomy (PTX) in patients with primary hyperparathyroid...
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal females or males > 50 years
- A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX
- aBMD T-score ≤ -1 at total hip, femoral neck, or lumbar spine
- 25-hydroxyvitamin D ≥ 50 nmol/l prior to randomization
- Willingness to undergo PTX
Exclusion Criteria:
- Known or suspected familial ethology (e.g., MEN1 or 2)
- Estimated glomerular filtration rate < 35 ml/min
- Known allergy to bisphosphonates
- 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.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06859580
Start Date
March 1 2025
End Date
February 1 2028
Last Update
March 25 2025
Active Locations (1)
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1
Aarhus University Hospital
Aarhus N, Central Region of Denmark, Denmark, 8200