Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity

J Clin Endocrinol Metab. 2011 Jan;96(1):E9-18. doi: 10.1210/jc.2010-1221. Epub 2010 Oct 13.


Context: Primary hyperparathyroidism (PHPT) is characterized by elevated serum calcium (Ca) and increased PTH concentrations.

Objective: The objective of the investigation was to establish the efficacy of cinacalcet in reducing serum Ca in patients with PHPT across a wide spectrum of disease severity.

Design and setting: The study was a pooled analysis of data from three multicenter clinical trials of cinacalcet in PHPT.

Patients: Patients were grouped into three disease categories for analysis based on the following: 1) history of failed parathyroidectomy (n = 29); 2) meeting one or more criteria for parathyroidectomy but without prior surgery (n = 37); and 3) mild asymptomatic PHPT without meeting criteria for either above category (n = 15).

Intervention: The intervention in this study was treatment with cinacalcet for up to 4.5 yr.

Outcomes: Measurements in the study included serum Ca, PTH, phosphate, and bone-specific alkaline phosphatase, and areal bone mineral density (aBMD). Vital signs, safety biochemical and hematological indices, and adverse events were monitored throughout the study period.

Results: The extent of cinacalcet-induced serum Ca reduction, proportion of patients achieving normal serum Ca (≤10.3 mg/dl), reduction in serum PTH, and increase in serum phosphate were similar across all three categories. Except for decreased aBMD at the total femur indicated for parathyroidectomy group at 1 yr, no significant changes in aBMD occurred. The efficacy of cinacalcet was maintained for up to 4.5 yr of follow-up. AEs were mild and similar across the three categories.

Conclusions: Cinacalcet is equally effective in the medical management of PHPT patients across a broad spectrum of disease severity, and overall cinacalcet is well tolerated.

Trial registration: NCT00001859 NCT00037518 NCT00936988.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorptiometry, Photon
  • Alkaline Phosphatase / blood
  • Analysis of Variance
  • Bone Density / drug effects
  • Calcium / blood
  • Cinacalcet
  • Double-Blind Method
  • Humans
  • Hypercalcemia / blood
  • Hypercalcemia / drug therapy*
  • Hypercalcemia / etiology
  • Hyperparathyroidism, Primary / blood
  • Hyperparathyroidism, Primary / complications
  • Hyperparathyroidism, Primary / drug therapy*
  • Naphthalenes / therapeutic use*
  • Parathyroid Hormone / blood
  • Parathyroidectomy
  • Phosphates / blood
  • Severity of Illness Index
  • Treatment Outcome


  • Naphthalenes
  • Parathyroid Hormone
  • Phosphates
  • Alkaline Phosphatase
  • Calcium
  • Cinacalcet

Associated data