HyperparathyroidismPara-KiTNCT07415421
Parathyroidectomy After Kidney Transplantation
A study testing Subtotal Parathyroidectomy and Conservative Management in people with Hyperparathyroidism and Kidney Transplantation Recipients, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
This study aims to clarify whether surgical treatment of persistent hyperparathyroidism after kidney transplantation offers clinically meaningful benefits compared with a conservative treatment strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism, Kidney Transplantation Recipients
- What is being tested?
- Subtotal Parathyroidectomy and Conservative Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Mar 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- On minimum two separate biochemical measurements:
- PTH > upper normal limit of assay and
- serum ionized calcium ≥1.33 mmol/L or
Show all 12Show fewer
- serum total calcium ≥2.60 mmol/L or
- serum phosphate ≤0.60 mmol/L despite sufficient dietary intake
- with measurements obtained within
- 3 months in patients 6-12 months post-transplant
- 6 months in patients >12 months post-transplant
- and not attributable to calcium supplementation or treatment with thiazide diuretics or lithium.
Who cannot join
- Inability to provide written, informed consent
- Current anti-resorptive therapy (bisphosphonate, denosumab)
- Current bone anabolic therapy (teriparatide, romosozumab)
- Previous surgical parathyroidectomy
- Not considered fit for surgery (including pregnancy)
- Ionized calcium ≥1.50 mmol/L or albumin-corrected calcium ≥3.00 mmol/L despite discontinuation of calcium supplements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Departement of Nephrology, Aarhus University hospital
Aarhus, Central Jutland, 8200
Hanne S Jørgensen, MD, PhD, +45 51 41 35 41, hsjorgensen@clin.au.dk
Amal Derai, MD, PhD, +45 51 36 03 80, amader@rm.dk
About this study
Official title: Subtotal Parathyroidectomy for the Treatment of Persistent Hyperparathyroidism After Kidney Transplantation
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.
Read the detailed description
Persistent hyperparathyroidism is a frequent complication after kidney transplantation. Despite improved kidney function, many transplant recipients continue to have elevated parathyroid hormone (PTH) levels, often accompanied by hypercalcemia and/or hypophosphatemia. These disturbances are associated with adverse effects on skeletal health and have been linked to increased risk of fractures, graft dysfunction, and mortality.
Currently, there are no evidence-based guidelines for the optimal management of persistent hyperparathyroidism after kidney transplantation. Conservative management with biochemical monitoring and supportive medical therapy is commonly used, while surgical parathyroidectomy is typically reserved for patients with severe biochemical abnormalities. Although parathyroidectomy is effective in normalizing PTH, calcium, and phosphate levels, and observational data suggest beneficial effects on bone mineral density, randomized controlled trials comparing surgical and conservative management strategies in this population are lacking.
The purpose of this study is to evaluate the safety and efficacy of subtotal parathyroidectomy compared with conservative management in kidney transplant recipients with persistent hyperparathyroidism.
The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period. Kidney transplant recipients (>6 mo after transplantation, no upper limit) 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. Controls will be treated with calcium, vitamin D and phosphate supplements as needed. Calcimimetic use is not mandated for controls, but can be utilized at the discretion of the treating physician.
The primary objective is to assess the change in bone mineral density at the total hip after 12 months.
Secondary objectives include evaluation of changes in mineral metabolism parameters, bone turnover markers, bone microarchitecture, physical function and muscle strength, quality of life and symptom burden, kidney graft function, and safety outcomes.
- Being tested
- Subtotal Parathyroidectomy, Conservative Management
- Keywords
- Persistent hyperparathyroidism, Kidney transplant recipients, Parathyroidectomy, Bone mineral density, Muscle function, Quality of life, Randomized controlled trial
- Medical subject headings
- Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtotal ParathyroidectomyProcedure or surgery
Subtotal 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 ManagementOther
Conservative 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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | Experimental | 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. Intraoperative parathyroid hormone (PTH) measurements will be used to guide the extent of resection, in accordance with standard surgical principles. Surgery will be performed by experienced ear, nose and throat (ENT) surgeons. Participants will receive standard perioperative care and postoperative follow-up. Receives: Procedure: Subtotal Parathyroidectomy |
| Control group | Active comparator | Participants assigned to this arm will receive conservative management according to standard clinical practice. This includes 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 at the discretion of the treating physician. No parathyroid surgery will be performed during the 12-month study period. Receives: Other: Conservative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to end of study at 12 months
Secondary outcomes (16)
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.
Measured: From baseline to end of study at 12 months
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.
Measured: From baseline to end of study at 12 months
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.
Measured: From baseline to end of study at 12 months
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
Measured: From baseline to end of study at 12 months
Bone turnover marker: Change in bone-specific alkaline phosphatase (BALP)
Bone-specific alkaline phosphataseBALP [µg/l] will be measured at baseline and 12 months. Outcome is change from baseline to 12 months.
Measured: From baseline to end of study at 12 months
Bone turnover marker: Change in plasma C-terminal crosslinks (CTX)
CTX [µg/L] will be measured at baseline and 12 months. Outcome is change from baseline to 12 months.
Measured: From baseline to end of study at 12 months
Bone turnover marker: Change in plasma procollagen type I N-terminal propeptide (PINP, intact and total forms)
Plasma procollagen type I N-terminal propeptide (PINP, intact and total forms) [µg/L] will be measured at baseline and 12 months. Outcome is change from baseline to 12 months.
Measured: From baseline to end of study at 12 months
Bone turnover marker: Change in plasma tartrate-resistant acid phosphatase isoform 5b (TRAP5b).
Plasma TRAP5b [U/L] will be measured at baseline and 12 months. Outcome is change from baseline to 12 months
Measured: From baseline to end of study at 12 months
Kidney function: Stability of kidney graft function based on estimated glomerular filtration rate (GFR) slope
Measured: From baseline to end of study at 12 months
Change in lower extremity function measured by the 30-second Chair Stand Test at 12 months
Lower extremity function will be assessed using the 30-second Chair Stand Test at baseline and after 12 months. The outcome is the change in the number of repetitions from baseline to 12 months, where a higher number of repetitions indicates better performance.
Measured: From baseline to end of study at 12 months.
Change in isometric lower extremity muscle strength
Isometric lower extremity muscle strength will be assessed using a dynamometer chair at baseline and after 12 months. The outcome is the change in maximal isometric strength from baseline to 12 months, where higher values indicate greater muscle strength.
Measured: From baseline to end of study at 12 months
Change in mobility measured by the Timed Up and Go (TUG) test
Mobility will be assessed using the Timed Up and Go (TUG) test at baseline and after 12 months. The outcome is the change in time (seconds) from baseline to 12 months, where a shorter time indicates better performance.
Measured: From baseline to end of study at 12 months.
Change in handgrip strength
Handgrip strength (HGS) test will be performed using a hand dynamometer at baseline and after 12 months. Handgrip strength will be measured in kilograms. The outcome is the change in handgrip strength from baseline to 12 months, where higher values indicate greater muscle strength.
Measured: From baseline to end of study at 12 months.
Change in quality of life measured by the Primary Hyperparathyroidism Quality of Life questionnaire (PHPQoL)
Quality of life will be assessed using the Primary Hyperparathyroidism Quality of Life questionnaire (PHPQoL) at baseline and after 12 months. The PHPQoL consists of 16 items assessing health-related quality of life in patients with hyperparathyroidism. Items are scored from 0 to 4 and summed to a total score of 0-64, which is subsequently normalized to a 0-100 scale, where higher scores indicate better quality of life. The outcome is the change in normalized PHPQoL total score from baseline to 12 months.
Measured: From baseline to end of study at 12 months.
Change in symptom burden measured by the Parathyroidectomy Assessment of Symptoms (PAS) score
Symptom burden will be assessed using the Parathyroidectomy Assessment of Symptoms (PAS) score at baseline and after 12 months. The PAS score consists of 13 symptom items, each scored from 0 (no symptoms) to 100 (maximum symptom severity), where higher scores indicate greater symptom burden. The outcome is the change in PAS total score from baseline to 12 months.
Measured: From baseline to end of study at 12 months.
Change in post-transplant quality of life measured by a SONG (Standardised Outcomes in Nephrology) -based questionnaire
Post-transplant quality of life will be assessed using a questionnaire developed for the post-transplant setting in collaboration with patient representatives (SONG initiative) at baseline and after 12 months. Items are scored using a five-point Likert scale with the response options: Never, Rarely, Sometimes, Usually, Always, with an additional Not applicable option. The outcome is the change in questionnaire score from baseline to 12 months.
Measured: From baseline to end of study at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start3 Mar 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Hanne S Jørgensen, MD, PhD, Principal investigator, Department of Nephrology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415421
- Sponsor's protocol ID
- 1-10-72-137-25
- Other IDs
- NNF22SA0079901
- Acronym
- Para-KiT
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications will be shared. This includes demographic data, baseline characteristics, outcome measures, and relevant laboratory and imaging data used for primary and secondary analyses. Data will be shared in an anonymized format to protect participant confidentiality. Only data necessary to reproduce the reported results will be made available. Additional data not included in publications will not be routinely shared. Data sharing will be conducted in accordance with applicable data protection regulations and national legislation.
Publications
Bandirali M, Lanza E, Messina C, Sconfienza LM, Brambilla R, Maurizio R, Marchelli D, Piodi LP, Di Leo G, Ulivieri FM, Sardanelli F. Dose absorption in lumbar and femoral dual energy X-ray absorptiometry examinations using three different scan modalities: an anthropomorphic phantom study. J Clin Densitom. 2013 Jul-Sep;16(3):279-282. doi: 10.1016/j.jocd.2013.02.005. Epub 2013 Mar 25.
PubMed 23535250Cianciolo G, Tondolo F, Barbuto S, Angelini A, Ferrara F, Iacovella F, Raimondi C, La Manna G, Serra C, De Molo C, Cavicchi O, Piccin O, D'Alessio P, De Pasquale L, Felisati G, Ciceri P, Galassi A, Cozzolino M. A roadmap to parathyroidectomy for kidney transplant candidates. Clin Kidney J. 2022 Feb 23;15(8):1459-1474. doi: 10.1093/ckj/sfac050. eCollection 2022 Aug.
PubMed 35892022Jorgensen HS, Claes K, Smout D, Naesens M, Kuypers D, D'Haese P, Cavalier E, Evenepoel P. Associations of Changes in Bone Turnover Markers with Change in Bone Mineral Density in Kidney Transplant Patients. Clin J Am Soc Nephrol. 2024 Apr 1;19(4):483-493. doi: 10.2215/CJN.0000000000000368. Epub 2023 Nov 29.
PubMed 38030558Jorgensen HS, Behets G, Bammens B, Claes K, Meijers B, Naesens M, Sprangers B, Kuypers DRJ, Cavalier E, D'Haese P, Evenepoel P. Natural History of Bone Disease following Kidney Transplantation. J Am Soc Nephrol. 2022 Mar;33(3):638-652. doi: 10.1681/ASN.2021081081. Epub 2022 Jan 19.
PubMed 35046132Abdelhadi M, Nordenstrom J. Bone mineral recovery after parathyroidectomy in patients with primary and renal hyperparathyroidism. J Clin Endocrinol Metab. 1998 Nov;83(11):3845-51. doi: 10.1210/jcem.83.11.5249.
PubMed 9814456Tong A, Budde K, Gill J, Josephson MA, Marson L, Pruett TL, Reese PP, Rosenbloom D, Rostaing L, Warrens AN, Wong G, Craig JC, Crowe S, Harris T, Hemmelgarn B, Manns B, Tugwell P, Van Biesen W, Wheeler DC, Winkelmayer WC, Evangelidis N, Sautenet B, Howell M, Chapman JR. Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation. Transplant Direct. 2016 May 19;2(6):e79. doi: 10.1097/TXD.0000000000000593. eCollection 2016 Jun.
PubMed 27500269Cheng SP, Lee JJ, Liu TP, Yang TL, Chen HH, Wu CJ, Liu CL. Parathyroidectomy improves symptomatology and quality of life in patients with secondary hyperparathyroidism. Surgery. 2014 Feb;155(2):320-8. doi: 10.1016/j.surg.2013.08.013. Epub 2013 Sep 11.
PubMed 24035616Pasieka JL, Parsons LL. A prospective surgical outcome study assessing the impact of parathyroidectomy on symptoms in patients with secondary and tertiary hyperparathyroidism. Surgery. 2000 Oct;128(4):531-9. doi: 10.1067/msy.2000.108117.
PubMed 11015085Bislev LS, Langagergaard Rodbro L, Sikjaer T, Rejnmark L. Effects of Elevated Parathyroid Hormone Levels on Muscle Health, Postural Stability and Quality of Life in Vitamin D-Insufficient Healthy Women: A Cross-Sectional Study. Calcif Tissue Int. 2019 Dec;105(6):642-650. doi: 10.1007/s00223-019-00612-2. Epub 2019 Sep 14.
PubMed 31522253Amstrup AK, Rejnmark L, Vestergaard P, Sikjaer T, Rolighed L, Heickendorff L, Mosekilde L. Vitamin D status, physical performance and body mass in patients surgically cured for primary hyperparathyroidism compared with healthy controls - a cross-sectional study. Clin Endocrinol (Oxf). 2011 Jan;74(1):130-6. doi: 10.1111/j.1365-2265.2010.03906.x.
PubMed 21044111Diaz-Tocados JM, Rodriguez-Ortiz ME, Almaden Y, Pineda C, Martinez-Moreno JM, Herencia C, Vergara N, Pendon-Ruiz de Mier MV, Santamaria R, Rodelo-Haad C, Casado-Diaz A, Lorenzo V, Carvalho C, Frazao JM, Felsenfeld AJ, Richards WG, Aguilera-Tejero E, Rodriguez M, Lopez I, Munoz-Castaneda JR. Calcimimetics maintain bone turnover in uremic rats despite the concomitant decrease in parathyroid hormone concentration. Kidney Int. 2019 May;95(5):1064-1078. doi: 10.1016/j.kint.2018.12.015. Epub 2019 Mar 12.
PubMed 30878213Collaud S, Staub-Zahner T, Trombetti A, Clerici T, Marangon N, Binet I, Myers PO, Rizzoli R, Martin PY, Robert JH, Triponez F. Increase in bone mineral density after successful parathyroidectomy for tertiary hyperparathyroidism after renal transplantation. World J Surg. 2008 Aug;32(8):1795-801. doi: 10.1007/s00268-008-9495-y.
PubMed 18311499Moreno P, Coloma A, Torregrosa JV, Montero N, Francos J, Codina S, Manonelles A, Bestard O, Garcia-Barrasa A, Melilli E, Cruzado JM. Long-term results of a randomized study comparing parathyroidectomy with cinacalcet for treating tertiary hyperparathyroidism. Clin Transplant. 2020 Aug;34(8):e13988. doi: 10.1111/ctr.13988. Epub 2020 Jun 3.
PubMed 32438479Cruzado JM, Moreno P, Torregrosa JV, Taco O, Mast R, Gomez-Vaquero C, Polo C, Revuelta I, Francos J, Torras J, Garcia-Barrasa A, Bestard O, Grinyo JM. A Randomized Study Comparing Parathyroidectomy with Cinacalcet for Treating Hypercalcemia in Kidney Allograft Recipients with Hyperparathyroidism. J Am Soc Nephrol. 2016 Aug;27(8):2487-94. doi: 10.1681/ASN.2015060622. Epub 2015 Dec 8.
PubMed 26647424Evenepoel P, Cooper K, Holdaas H, Messa P, Mourad G, Olgaard K, Rutkowski B, Schaefer H, Deng H, Torregrosa JV, Wuthrich RP, Yue S. A randomized study evaluating cinacalcet to treat hypercalcemia in renal transplant recipients with persistent hyperparathyroidism. Am J Transplant. 2014 Nov;14(11):2545-55. doi: 10.1111/ajt.12911. Epub 2014 Sep 15.
PubMed 25225081
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtotal Parathyroidectomy for the Treatment of Persistent Hyperparathyroidism After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT07415421
- Acronym / sponsor ID
- Para-KiT / 1-10-72-137-25
- Keywords
- Persistent hyperparathyroidism, Kidney transplant recipients, Parathyroidectomy, Bone mineral density, Muscle function, Quality of life, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Persistent hyperparathyroidism is a frequent complication after kidney transplantation. Despite improved kidney function, many transplant recipients continue to have elevated parathyroid hormone (PTH) levels, often accompanied by hypercalcemia and/or hypophosphatemia. These disturbances are associated with adverse effects on skeletal health and have been linked to increased risk of fractures, graft dysfunction, and mortality.
Currently, there are no evidence-based guidelines for the optimal management of persistent hyperparathyroidism after kidney transplantation. Conservative management with biochemical monitoring and supportive medical therapy is commonly used, while surgical parathyroidectomy is typically reserved for patients with severe biochemical abnormalities. Although parathyroidectomy is effective in normalizing PTH, calcium, and phosphate levels, and observational data suggest beneficial effects on bone mineral density, randomized controlled trials comparing surgical and conservative management strategies in this population are lacking.
The purpose of this study is to evaluate the safety and efficacy of subtotal parathyroidectomy compared with conservative management in kidney transplant recipients with persistent hyperparathyroidism.
The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period. Kidney transplant recipients (>6 mo after transplantation, no upper limit) 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. Controls will be treated with calcium, vitamin D and phosphate supplements as needed. Calcimimetic use is not mandated for controls, but can be utilized at the discretion of the treating physician.
The primary objective is to assess the change in bone mineral density at the total hip after 12 months.
Secondary objectives include evaluation of changes in mineral metabolism parameters, bone turnover markers, bone microarchitecture, physical function and muscle strength, quality of life and symptom burden, kidney graft function, and safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group | Experimental | Procedure: Subtotal ParathyroidectomyParticipants 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. Intraoperative parathyroid hormone (PTH) measurements will be used to guide the extent of resection, in accordance with standard surgical principles. Surgery will be performed by experienced ear, nose and throat (ENT) surgeons. Participants will receive standard perioperative care and postoperative follow-up. |
| Control group | Active comparator | Other: Conservative ManagementParticipants assigned to this arm will receive conservative management according to standard clinical practice. This includes 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 at the discretion of the treating physician. No parathyroid surgery will be performed during the 12-month study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- On minimum two separate biochemical measurements:
- PTH > upper normal limit of assay and
Key exclusion criteria (6 listed)
- Inability to provide written, informed consent
- Current anti-resorptive therapy (bisphosphonate, denosumab)
- Current bone anabolic therapy (teriparatide, romosozumab)
- Previous surgical parathyroidectomy
- Not considered fit for surgery (including pregnancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subtotal ParathyroidectomySubtotal 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. | Procedure or surgery | Surgery group |
| Conservative ManagementConservative 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. | Other | Control group |
Primary outcome
Change in bone mineral density (BMD) at the total hip
Time frame: From baseline to end of study at 12 months
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.
16 secondary outcomes
Changes in cortical and trabecular bone microarchitecture
Time frame: From baseline to end of study at 12 months
Mineral metabolism: Change in plasma parathyroid hormone (PTH)
Time frame: From baseline to end of study at 12 months
Mineral metabolism: Changes in serum ionized calcium and phosphate
Time frame: From baseline to end of study at 12 months
Mineral metabolism: Change in plasma fibroblast growth factor 23 (FGF23)
Time frame: From baseline to end of study at 12 months
Bone turnover marker: Change in bone-specific alkaline phosphatase (BALP)
Time frame: From baseline to end of study at 12 months
Bone turnover marker: Change in plasma C-terminal crosslinks (CTX)
Time frame: From baseline to end of study at 12 months
Bone turnover marker: Change in plasma procollagen type I N-terminal propeptide (PINP, intact and total forms)
Time frame: From baseline to end of study at 12 months
Bone turnover marker: Change in plasma tartrate-resistant acid phosphatase isoform 5b (TRAP5b).
Time frame: From baseline to end of study at 12 months
Kidney function: Stability of kidney graft function based on estimated glomerular filtration rate (GFR) slope
Time frame: From baseline to end of study at 12 months
Change in lower extremity function measured by the 30-second Chair Stand Test at 12 months
Time frame: From baseline to end of study at 12 months.
Change in isometric lower extremity muscle strength
Time frame: From baseline to end of study at 12 months
Change in mobility measured by the Timed Up and Go (TUG) test
Time frame: From baseline to end of study at 12 months.
Change in handgrip strength
Time frame: From baseline to end of study at 12 months.
Change in quality of life measured by the Primary Hyperparathyroidism Quality of Life questionnaire (PHPQoL)
Time frame: From baseline to end of study at 12 months.
Change in symptom burden measured by the Parathyroidectomy Assessment of Symptoms (PAS) score
Time frame: From baseline to end of study at 12 months.
Change in post-transplant quality of life measured by a SONG (Standardised Outcomes in Nephrology) -based questionnaire
Time frame: From baseline to end of study at 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 23535250Bandirali M, Lanza E, Messina C, Sconfienza LM, Brambilla R, Maurizio R, Marchelli D, Piodi LP, Di Leo G, Ulivieri FM, Sardanelli F. Dose absorption in lumbar and femoral dual energy X-ray absorptiometry examinations using three different scan modalities: an anthropomorphic phantom study. J Clin Densitom. 2013 Jul-Sep;16(3):279-282. doi: 10.1016/j.jocd.2013.02.005. Epub 2013 Mar 25.
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- Background: PubMed 38030558Jorgensen HS, Claes K, Smout D, Naesens M, Kuypers D, D'Haese P, Cavalier E, Evenepoel P. Associations of Changes in Bone Turnover Markers with Change in Bone Mineral Density in Kidney Transplant Patients. Clin J Am Soc Nephrol. 2024 Apr 1;19(4):483-493. doi: 10.2215/CJN.0000000000000368. Epub 2023 Nov 29.
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- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in publications will be shared. This includes demographic data, baseline characteristics, outcome measures, and relevant laboratory and imaging data used for primary and secondary analyses. Data will be shared in an anonymized format to protect participant confidentiality. Only data necessary to reproduce the reported results will be made available. Additional data not included in publications will not be routinely shared. Data sharing will be conducted in accordance with applicable data protection regulations and national legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanne S Jørgensen, MD, PhD principal investigator
Department of Nephrology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subtotal Parathyroidectomy and Conservative Management in people with Hyperparathyroidism and Kidney Transplantation Recipients, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanne S Jørgensen, MD, PhD (+45 51 41 35 41, hsjorgensen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone mineral density (BMD) at the total hip (time frame: From baseline to end of study at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07415421, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.