Cinacalcet Hydrochloride Reduces the Serum Calcium Concentration in Inoperable Parathyroid Carcinoma
Open Access
- 1 October 2007
- journal article
- clinical trial
- Published by The Endocrine Society in Journal of Clinical Endocrinology & Metabolism
- Vol. 92 (10), 3803-3808
- https://doi.org/10.1210/jc.2007-0585
Abstract
Background: Management of inoperable parathyroid carcinoma presents a challenge because until recently, effective medical therapy was not available. Morbidity and mortality result primarily from severe hypercalcemia. We assessed the ability of the calcimimetic cinacalcet HCl to reduce serum calcium in patients with parathyroid carcinoma as well as its effect on PTH concentrations, bone turnover markers, safety, and health-related quality of life variables. Methods: Twenty-nine patients with parathyroid carcinoma were enrolled in this open-label, single-arm study consisting of titration and maintenance phases. Cinacalcet doses were titrated (30 mg twice daily to 90 mg four times daily) for 16 wk or until serum calcium was no more than 10.0 mg/dl. The study endpoint was the proportion of patients with at least a 1 mg/dl reduction in serum calcium at the end of the titration phase (responders). Results: Mean (± se) serum calcium (14.1 ± 0.4 mg/dl) and PTH (697 ± 94 pg/ml) were markedly elevated at baseline. At the end of the titration period, serum calcium was reduced by at least 1 mg/dl in 62% of patients (mean decline to 12.4 ± 0.5 mg/dl). In the 18 responders, serum calcium fell from 15.0 ± 0.5 to 11.2 ± 0.3 mg/dl (P < 0.001). The greatest reductions in serum calcium were observed in patients with highest baseline calcium levels. PTH levels decreased, but not significantly, to 635 ± 73 pg/ml (−4.6%). Adverse events included nausea, vomiting, headache, and fracture. Conclusions: Cinacalcet effectively reduces hypercalcemia in approximately two thirds of patients with inoperable parathyroid carcinoma and may represent an important new treatment option for these patients.Keywords
This publication has 24 references indexed in Scilit:
- Increased Parathyroid Hormone Gene Expression in Secondary Hyperparathyroidism of Experimental Uremia Is Reversed by CalcimimeticsJournal of the American Society of Nephrology, 2006
- Cinacalcet HCl, an Oral Calcimimetic Agent for the Treatment of Secondary Hyperparathyroidism in Hemodialysis and Peritoneal DialysisJournal of the American Society of Nephrology, 2005
- Cinacalcet HCl attenuates parathyroid hyperplasia in a rat model of secondary hyperparathyroidismKidney International, 2005
- No Effect of Renal Function or Dialysis on Pharmacokinetics of Cinacalcet (Sensipar??/Mimpara??)Clinical Pharmacokinetics, 2005
- Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving HemodialysisThe New England Journal of Medicine, 2004
- Pharmacodynamics of the Type II Calcimimetic Compound Cinacalcet HClThe Journal of pharmacology and experimental therapeutics, 2003
- Prolonged remission of hypercalcaemia due to parathyroid carcinoma with pamidronatePublished by Oxford University Press (OUP) ,1994
- Cloning and characterization of an extracellular Ca2+-sensing receptor from bovine parathyroidNature, 1993
- ORAL BIPHOSPHONATE THERAPY IN METASTATIC PARATHYROID CARCINOMAThe Lancet, 1985
- DISODIUM CLODRONATE EFFECTIVE IN MANAGEMENT OF SEVERE HYPERCALCAEMIA CAUSED BY PARATHYROID CARCINOMAThe Lancet, 1984