A Randomized Study Comparing Parathyroidectomy with Cinacalcet for Treating Hypercalcemia in Kidney Allograft Recipients with Hyperparathyroidism.
Cruzado JM, Moreno P, et al.J Am Soc Nephrol 2015 [record in progress]
Aims
To evaluate whether subtotal parathyroidectomy is more effective than cinacalcet for controlling hypercalcemia caused by persistent hyperparathyroidism after kidney transplant.
Interventions
Patients were randomized to receive cinacalcet oral treatment (30 mg/d, adjusted to achieve normocalcemia) or undergo a subtotal parathyroidectomy
Participants
30 kidney transplant recipients with hypercalcemia and elevated intact parathyroid hormone (iPTH) concentration
Outcomes
The primary outcome measured was the proportion of patients with normocalcemia at 12months. Secondary outcomes were serumiPTH, serum phosphate, bone turnover biomarkers of bone mineral density and vascular calcification, renal function, patient and graft survival, and economic cost associated with each treatment.
Follow-up
12 months
CET Conclusions
This is a very nice trial which has not been attempted before, namely to compare subtotal parathyroidectomy with cinacalcet for treating hypercalcaemia in renal transplant patients with tertiary hyperthyroidism. Eligible patients had to be hypercalcaemic, have a raised intact parathyroid hormone and be at least six months after transplantation. Thirty patients who met the inclusion criteria were randomised on a one to one basis to receive either cinacalcet or subtotal parathyroidectomy. Starting dose of cinacalcet was 30 mgs per day and all the parathyroidectomies were performed by the same surgeon, and intact PTH was measured before and ten minutes after surgery to indicate that the parathyroidectomy had been successful. The primary end-point was normocalcaemia at 12 months after treatment, and this was achieved in all patients who had a parathyroidectomy, but in only 10 of 15 patients who were treated with cinacalcet. There was also a greater reduction of intact PTH and this was associated with an insignificant increase in femoral neck bone mineral density in the surgery group. Frequent adverse events were digestive intolerance in the cinacalcet group and hypocalcaemia in the parathyroidectomy group. The investigators also evaluated the cost of the two treatments and at 14 months after treatment a subtotal parathyroidectomy would prove to be more cost effective than cinacalcet. This is an important contribution to the management of hyperparathyroidism in renal transplant recipients.
Data analysis
Strict intention-to-treat analysis
Trial registration
EudraCT -2008–007017–76; ClinicalTrials.gov - NCT01178450