Cinacalcet hydrochloride reduces the serum calcium concentration in inoperable parathyroid carcinoma

Shonni J. Silverberg, M. R. Rubin, C. Faiman, M. Peacock, D. M. Shoback, Robert Christian Smallridge, L. E. Schwanauer, K. A. Olson, P. Klassen, J. P. Bilezikian

Research output: Contribution to journalArticle

152 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)3803-3808
Number of pages6
JournalJournal of Clinical Endocrinology and Metabolism
Volume92
Issue number10
DOIs
StatePublished - Oct 2007

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Parathyroid Neoplasms
Calcium
Serum
Titration
Hypercalcemia
Cinacalcet Hydrochloride
Bone Remodeling
Nausea
Vomiting
Headache
Labels
Bone
Maintenance
Quality of Life
Health
Morbidity
Safety
Mortality
Therapeutics

ASJC Scopus subject areas

  • Biochemistry
  • Endocrinology, Diabetes and Metabolism

Cite this

Cinacalcet hydrochloride reduces the serum calcium concentration in inoperable parathyroid carcinoma. / Silverberg, Shonni J.; Rubin, M. R.; Faiman, C.; Peacock, M.; Shoback, D. M.; Smallridge, Robert Christian; Schwanauer, L. E.; Olson, K. A.; Klassen, P.; Bilezikian, J. P.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 92, No. 10, 10.2007, p. 3803-3808.

Research output: Contribution to journalArticle

Silverberg, SJ, Rubin, MR, Faiman, C, Peacock, M, Shoback, DM, Smallridge, RC, Schwanauer, LE, Olson, KA, Klassen, P & Bilezikian, JP 2007, 'Cinacalcet hydrochloride reduces the serum calcium concentration in inoperable parathyroid carcinoma', Journal of Clinical Endocrinology and Metabolism, vol. 92, no. 10, pp. 3803-3808. https://doi.org/10.1210/jc.2007-0585
Silverberg, Shonni J. ; Rubin, M. R. ; Faiman, C. ; Peacock, M. ; Shoback, D. M. ; Smallridge, Robert Christian ; Schwanauer, L. E. ; Olson, K. A. ; Klassen, P. ; Bilezikian, J. P. / Cinacalcet hydrochloride reduces the serum calcium concentration in inoperable parathyroid carcinoma. In: Journal of Clinical Endocrinology and Metabolism. 2007 ; Vol. 92, No. 10. pp. 3803-3808.
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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.",
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AU - Silverberg, Shonni J.

AU - Rubin, M. R.

AU - Faiman, C.

AU - Peacock, M.

AU - Shoback, D. M.

AU - Smallridge, Robert Christian

AU - Schwanauer, L. E.

AU - Olson, K. A.

AU - Klassen, P.

AU - Bilezikian, J. P.

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N2 - 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.

AB - 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.

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