Parathyroidectomy After Kidney Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
This study aims to clarify whether surgical treatment of persistent hyperparathyroidism after kidney transplantation offers clinically meaningful benefits compared with a conservative treatment strategy.
Kidney transplant recipients (\>6 mo after transplantation) with persistent hyperparathyroidism (elevated PTH and either hypercalcemia or hypophosphatemia) will be randomized in a 1:1 ratio to either subtotal parathyroidectomy or conservative management according to standard clinical practice. The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period.
Outcomes include bone density, physical function, quality of life and symptom burden.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years and legally competent and able to understand spoken and written Danish
Kidney transplantation ≥6 months prior (no upper limit of time after transplantation)
Stable kidney graft function, defined as estimated GFR ≥ 30 ml/min/1.73m3
serum ionized calcium ≥1.33 mmol/L or
Disqualifiers
Inability to provide written, informed consent
Current anti-resorptive therapy (bisphosphonate, denosumab)
Current bone anabolic therapy (teriparatide, romosozumab)
Previous surgical parathyroidectomy
Trial design
Design model
Parallel
Treatments tested in this trial
Subtotal Parathyroidectomy
Procedure/SurgerySubtotal parathyroidectomy performed according to standard surgical practice. The procedure involves removal of the majority of parathyroid tissue with preservation of a small remnant. Intraoperative parathyroid hormone (PTH) measurements are used to guide the extent of resection. Standard perioperative care and postoperative follow-up are provided.
Conservative Management
Other interventionConservative management according to standard clinical practice, including regular clinical follow-up and biochemical monitoring of calcium, phosphate, and parathyroid hormone levels. Medical treatment, such as calcium or vitamin D supplementation and/or calcimimetic therapy, may be initiated or adjusted based on clinical judgment.
Treatment groups
85 Participants
are divided into 2 treatment groupsGroup A: Surgery groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in bone mineral density (BMD) at the total hip
Bone mineral density (BMD) at the total hip will be measured using dual-energy X-ray absorptiometry (DXA) according to standardized procedures. Measurements will be performed at baseline and after 12 months. The primary outcome is the change in bone mineral density from baseline to 12 months.
Time frame
From baseline to end of study at 12 monthsSecondary outcomes
1
Changes in cortical and trabecular bone microarchitecture
Bone microarchitecture will be assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT) at baseline and after 12 months. Parameters will include measures of trabecular and cortical bone structure. The outcome is the change in these parameters from baseline to 12 months.
Time frame
From baseline to end of study at 12 months2
Mineral metabolism: Change in plasma parathyroid hormone (PTH)
Plasma plasma parathyroid hormone PTH \[pmol/L\] will be measured at baseline and 12 months. Outcome is change from baseline to 12 months.
Time frame
From baseline to end of study at 12 months3
Mineral metabolism: Changes in serum ionized calcium and phosphate
Serum ionized calcium \[mmol/L\] and phosphate \[mmol/L\] will be measured at baseline and 12 months. Outcome is change from baseline to 12 months.
Time frame
From baseline to end of study at 12 months4
Mineral metabolism: Change in plasma fibroblast growth factor 23 (FGF23)
Plasma fibroblast growth factor 23 FGF23 \[ng/L\] will be measured at baseline and 12 months. Outcome is change from baseline to 12 months
Time frame
From baseline to end of study at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aarhus University Hospital
Lead sponsor
University of Aarhus
Collaborator
Source ClinicalTrials.gov