NCT06859580 Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
| NCT ID | NCT06859580 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Aarhus |
| Condition | Primary Hyperparathyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2025-03-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 BMD, bone microarchitecture, bone turnover markers, coronary artery calcium score, arterial stiffness, and renal calcifications. A total of 140 postmenopausal women and men over 50 years with PHPT and low BMD will be enrolled and randomized to receive either ZOL or placebo 2-4 weeks before PTX. Participants will undergo extensive imaging, biochemical analysis, and cardiovascular assessments at baseline and one year post-surgery. This study seeks to clarify whether ZOL improves post-surgical bone recovery or interferes with the natural bone remodeling process following PTX. Additionally, it will provide insight into the cardiovascular and renal effects of bisphosphonate therapy in PHPT patients. Findings may help guide treatment strategies for optimizing long-term skeletal and systemic health in this patient population.
Eligibility Criteria
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.
Contact & Investigator
Lars Rejnmark, Professor
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06859580 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Primary Hyperparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06859580 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06859580 currently recruiting?
Yes, NCT06859580 is actively recruiting participants. Contact the research team at ansvnn@rm.dk for enrollment information.
Where is the NCT06859580 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT06859580 clinical trial?
NCT06859580 is sponsored by University of Aarhus. The principal investigator is Lars Rejnmark, Professor at Aarhus University Hospital. The trial plans to enroll 140 participants.