About this trial
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
This trial does not accept healthy volunteersQualifiers
Females or males > 40 years
A diagnosis of hyperparathyroid hypercalcemia due to sporadic PHPT referred to PTX
aBMD T-score or Z-score ≤ -1 at total hip, femoral neck, distal forearm, or lumbar spine
25-hydroxyvitamin D ≥ 50 nmol/l prior to randomization
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Zoledronic acid 4 mg
DrugProduct name/EU MP number: Zoledronic Acid Oresund Pharma 4 mg/100 ml infusionsvätska, lösning/PRD8924813 (Test) Substance (name/ code): ZOLEDRONIC ACID/SUB00176MIG Strength: Zoledronic Acid 0.04mg Pharmaceutical form: SOLUTION FOR INFUSION Route of administration: INFUSIÓN INTRAVENOSA Marketing authorisation status (MA number, MS where authorised etc): 52486 / SE Modified in relation to MA: No Max Dosage: mg milligram(s) Duration of use: Week
Natriumklorid 9 mg/ml, Fresenius Kabi
DrugProduct name/EU MP number: Natriumklorid "Baxter" ClearFlex 9 mg/ml,infusionsvæske, opløsning/PRD456031 (Placebo) Substance (name/ code): SODIUM CHLORIDE/SUB12581MIG Strength: Sodium Chloride 0.9g / 100mL Pharmaceutical form: SOLUTION FOR INFUSION Route of administration: INFUSIÓN INTRAVENOSA Marketing authorisation status (MA number, MS where authorised etc): 32466 / DK Modified in relation to MA: No Max Dosage: ml millilitre(s) Duration of use: Week
Treatment groups
Trial outcomes
Primary outcomes
Effects of ZOL vs. placebo at time of parathyroidectomy based on change in aBMD at lumbar spine meased at baseline compared to one year after PTX.
aBMD (g/cm\^3) will be measured by DXA-scans at baseline and one year after PTX.
Secondary outcomes
Effects of ZOL at aBMD at distal forearm
A change in aBMD (g/cm\^3) at distal forearm will be measured by DXA-scans at baseline and 12 month after PTX.
Effects of ZOL at aBMD at femoral neck
A change in aBMD (g/cm\^3) at femoral neck will be measured by DXA-scans at baseline and 12 month after PTX.
Effects of ZOL at aBMD at total hip
A change in aBMD (g/cm\^3) at total hip will be measured by DXA-scans at baseline and 12 month after PTX.
Effects on microarchitecture measured by high-resolution peripheral computed tomography (HRpQCT).
Bone microarchitecture will be measured by HRPqCT scans and changes will be assessed from baseline to 12 months after PTX.
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