Dose absorption in lumbar and femoral dual energy X-ray absorptiometry examinations using three different scan modalities: an anthropomorphic phantom study.
Michele Bandirali, Ezio Lanza, Carmelo Messina...
https://pubmed.ncbi.nlm.nih.gov/23535250Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07415421
Subtotal Parathyroidectomy for Persistent Hyperparathyroidism After Kidney Transplantation
Led by Aarhus University Hospital · Updated on 2026-02-17
85
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aarhus University Hospital
Lead Sponsor
U
University of Aarhus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether surgical treatment through subtotal parathyroidectomy offers meaningful benefits compared to conservative management for kidney transplant recipients who have persistent hyperparathyroidism, a condition involving elevated parathyroid hormone levels often with abnormal calcium or phosphate levels. This condition can negatively affect bone health and increase risks such as fractures and graft complications. The study is an open-label, randomized controlled pilot trial with a 12-month follow-up period. Participants will be randomly assigned to one of two groups: one group will undergo subtotal parathyroidectomy, a surgery removing most of the parathyroid tissue while preserving a small part, guided by hormone measurements and performed by experienced surgeons. The other group will receive conservative management including regular clinical and biochemical monitoring and may receive calcium, vitamin D, or calcimimetic medications as needed. No surgery will be performed in this group during the study period. During the 12 months, participants will have assessments including bone mineral density scans at the hip, evaluations of bone structure and metabolism, muscle strength and physical function tests, quality of life questionnaires, and monitoring of kidney graft function and safety. Outcomes such as changes in bone density, hormone and mineral levels, physical function, symptom burden, and quality of life will be measured to help clarify the safety and effectiveness of surgery versus conservative care in this patient group.
CONDITIONS
Brief Title
Parathyroidectomy After Kidney Transplantation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age > 18 years and legally competent and able to understand spoken and written Danish
- Kidney transplantation 6 months or more prior, with no upper time limit
- Stable kidney graft function with estimated GFR ≥ 30 ml/min/1.73m2
- Two consecutive biochemical measurements showing PTH ≥ 1.5 times normal and ionized calcium ≥ 1.35 mmol/L or albumin-corrected calcium ≥ 2.70 mmol/L or phosphate ≤ 0.50 mmol/L
You will not qualify if you...
- Unable to provide written, informed consent
- Current treatment with anti-resorptive drugs such as bisphosphonate or denosumab
- Current treatment with bone anabolic drugs such as teriparatide or romosozumab
- Previous surgical parathyroidectomy
- Not fit for surgery, including pregnancy
- Ionized calcium ≥ 1.50 mmol/L or albumin-corrected calcium ≥ 3.00 mmol/L despite stopping calcium supplements during screening period or before
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Subtotal Parathyroidectomy
Duration - Procedure with standard perioperative and postoperative care
Participants assigned to this arm will undergo subtotal parathyroidectomy performed according to standard surgical practice. The procedure involves removal of the majority of parathyroid tissue with preservation of a small remnant. Standard perioperative care and postoperative follow-up are provided.
Surgery visit and several postoperative visits
Conservative Management
Duration - 12 months
Participants assigned to this arm will receive conservative management including regular clinical follow-up and biochemical monitoring of calcium, phosphate, and parathyroid hormone levels. Medical treatments such as calcium, vitamin D supplementation, or calcimimetic therapy may be adjusted as needed.
Regular clinical and biochemical monitoring visits during 12 months
Follow-up
Duration - 12 months
Participants are followed for 12 months to assess changes in bone mineral density, mineral metabolism, physical function, quality of life, and kidney graft function.
Scheduled follow-up visits during the 12-month period
Trial Site Locations
Total: 1 location
1
Departement of Nephrology, Aarhus University hospital
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
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Research Team
H
Hanne S Jørgensen, MD, PhD
A
Amal Derai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
A roadmap to parathyroidectomy for kidney transplant candidates.
Giuseppe Cianciolo, Francesco Tondolo, Simona Barbuto...
https://pubmed.ncbi.nlm.nih.gov/35892022Associations of Changes in Bone Turnover Markers with Change in Bone Mineral Density in Kidney Transplant Patients.
Hanne Skou Jørgensen, Kathleen Claes, Dieter Smout...
https://pubmed.ncbi.nlm.nih.gov/38030558Natural History of Bone Disease following Kidney Transplantation.
Hanne Skou Jørgensen, Geert Behets, Bert Bammens...
https://pubmed.ncbi.nlm.nih.gov/35046132Bone mineral recovery after parathyroidectomy in patients with primary and renal hyperparathyroidism.
M Abdelhadi, J Nordenström
https://pubmed.ncbi.nlm.nih.gov/9814456Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation.
Allison Tong, Klemens Budde, John Gill...
https://pubmed.ncbi.nlm.nih.gov/27500269Parathyroidectomy improves symptomatology and quality of life in patients with secondary hyperparathyroidism.
Shih-Ping Cheng, Jie-Jen Lee, Tsang-Pai Liu...
https://pubmed.ncbi.nlm.nih.gov/24035616A prospective surgical outcome study assessing the impact of parathyroidectomy on symptoms in patients with secondary and tertiary hyperparathyroidism.
J L Pasieka, L L Parsons
https://pubmed.ncbi.nlm.nih.gov/11015085Effects of Elevated Parathyroid Hormone Levels on Muscle Health, Postural Stability and Quality of Life in Vitamin D-Insufficient Healthy Women: A Cross-Sectional Study.
Lise Sofie Bislev, Lene Langagergaard Rødbro, Tanja Sikjær...
https://pubmed.ncbi.nlm.nih.gov/31522253Vitamin D status, physical performance and body mass in patients surgically cured for primary hyperparathyroidism compared with healthy controls - a cross-sectional study.
Anne Kristine Amstrup, Lars Rejnmark, Peter Vestergaard...
https://pubmed.ncbi.nlm.nih.gov/21044111