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Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism

Study acronym: ZOLPHPT
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Minor Interventions: Natriumklorid 9 mg/ml, Fresenius Kabi (Drug), Zoledronic acid 4 mg (Drug) to Natriumklorid 9 mg/ml, Fresenius Kabi (Drug), Zoledronic acid 4 mg (Drug) Show 4 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 11 entries
    • Study description expanded, about 12 words
    • Publications: details revised at 43 of 45 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  3. Minor Secondary endpoints: 7 to 11
    • Study description shortened, about 592 words
    • Site contact updated
    • Publications: 1 to 45
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06859580
Lead Sponsor University of Aarhus
Conditions
(from sponsor)
Primary Hyperparathyroidism
Related terms Hyperparathyroidism, Primary
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov