title: Cinacalcet normalizes serum calcium in a double-blind randomized, placebo-controlled study in patients with primary hyperparathyroidism with contraindications to surgery.
abstract: OBJECTIVE
  Primary hyperparathyroidism (PHPT) is diagnosed by the presence of hypercalcemia and elevated or nonsuppressed parathyroid hormone (PTH) levels. Although surgery is usually curative, some individuals fail or are unable or unwilling to undergo parathyroidectomy. In such individuals, targeted medical therapy may be of value. Cinacalcet normalized calcium level and lowered PTH in patients with PHPT in several phase 2 and open-label studies. We compared cinacalcet and placebo in subjects with PHPT unable to undergo parathyroidectomy.
  
  
  METHODS
  Phase 3, double-blind, multi centere, randomized, placebo-controlled study.
  
  
  METHODS
  Sixty-seven subjects (78% women) with moderate PHPT were randomized (1:1) to cinacalcet or placebo for ≤28 weeks.
  
  
  METHODS
  Achievement of a normal mean corrected total serum calcium concentration of ≤10.3 mg/dl (2.575 mmol/l).
  
  
  RESULTS
  Baseline median (quartile 1 (Q1), Q3) serum PTH was 164.0 (131.0, 211.0) pg/ml and mean (s.d.) serum Ca was 11.77 (0.46) mg/dl. Serum Ca normalized (≤10.3 mg/dl) in 75.8% of cinacalcet- vs 0% of placebo-treated subjects (P<0.001). Corrected serum Ca decreased by ≥1.0 mg/dl from baseline in 84.8% of cinacalcet- vs 5.9% of placebo-treated subjects (P<0.001). Least squares mean (s.e.m.) plasma PTH change from baseline was -23.80% (4.18%) (cinacalcet) vs -1.01% (4.05%) (placebo) (P<0.001). Similar numbers of subjects in the cinacalcet and placebo groups reported adverse events (AEs) (27 vs 20) and serious AEs (three vs four). Most commonly reported AEs were nausea and muscle spasms.
  
  
  CONCLUSIONS
  These results demonstrate that cinacalcet normalizes serum calcium in this PHPT population and appears to be well tolerated.
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary draliyakhan@gmail.com.
authors: Aliya
authors: A
authors: Khan
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary.
authors: John
authors: J
authors: Bilezikian
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary.
authors: Henry
authors: H
authors: Bone
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary.
authors: Andrey
authors: A
authors: Gurevich
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary.
authors: Peter
authors: P
authors: Lakatos
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary.
authors: Waldemar
authors: W
authors: Misiorowski
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary.
authors: Liudmila
authors: L
authors: Rozhinskaya
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary.
authors: Marie-Louise
authors: ML
authors: Trotman
authors: Divisions of Endocrinology and GeriatricsMcMaster University, 331-209 Sheddon Avenue, Oakville, Ontario, Canada L6J 1X8College of Physicians and SurgeonsColumbia University, New York, New York, USAMichigan Bone and Mineral ClinicDetroit, Michigan, USAAmgen (Europe) GmbHZug, Switzerland1st Department of MedicineSemmelweis University Medical School, Budapest, HungaryDepartment of EndocrinologyMedical Centre of Postgraduate Education, Warsaw, PolandEndocrinology Research CentreMoscow, RussiaAmgenInc., Thousand Oaks, California, USA2nd Department of MedicineSemmelweis University, Budapest, Hungary.
authors: Miklós
authors: M
authors: Tóth
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000069449:Cinacalcet; D000075202:Contraindications; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006934:Hypercalcemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology*; D006961:Hyperparathyroidism / Q000097:blood* / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D016105:Parathyroidectomy; D010758:Phosphorus / Q000097:blood
chemical_list: D009281:Naphthalenes; D010758:Phosphorus; D000069449:Cinacalcet
references: Kidney Int. 2005 Feb;67(2):760-71
references: 15673327
references: J Clin Endocrinol Metab. 2009 Feb;94(2):335-9
references: 19193908
references: World J Surg. 2002 Aug;26(8):942-9
references: 12016473
references: J Endocrinol Invest. 2012 Jan;35(1):90-5
references: 22104762
references: J Clin Endocrinol Metab. 2004 Jul;89(7):3319-25
references: 15240609
references: J Clin Endocrinol Metab. 2013 Feb;98(2):721-8
references: 23365127
references: Nephrol Dial Transplant. 2003 Dec;18(12):2467-70
references: 14605264
references: J Clin Endocrinol Metab. 2003 Dec;88(12):5644-9
references: 14671147
references: Surgery. 2000 Dec;128(6):1013-20;discussion 1020-1
references: 11114637
references: J Clin Endocrinol Metab. 2005 Apr;90(4):2122-6
references: 15644400
references: Otolaryngol Head Neck Surg. 2005 Mar;132(3):359-72
references: 15746845
references: J Clin Endocrinol Metab. 2009 Aug;94(8):2766-72
references: 19470620
references: Med Care. 1992 Jun;30(6):473-83
references: 1593914
references: J Clin Endocrinol Metab. 2002 Dec;87(12):5353-61
references: 12466320
references: J Clin Densitom. 2013 Jan-Mar;16(1):54-9
references: 23374742
references: Surgery. 2009 Dec;146(6):1116-22
references: 19879613
references: J Clin Endocrinol Metab. 2009 Dec;94(12):4860-7
references: 19837909
references: J Clin Endocrinol Metab. 2009 Feb;94(2):340-50
references: 19193909
references: Endocrine. 2011 Jun;39(3):283-7
references: 21445714
references: Eur J Endocrinol. 2014 Dec;171(6):727-35
references: 25240499
references: J Clin Endocrinol Metab. 2014 Oct;99(10):3561-9
references: 25162665
references: J Clin Endocrinol Metab. 2011 Jan;96(1):E9-18
references: 20943783
references: Eur J Endocrinol. 2012 Aug;167(2):157-64
references: 22577108
references: J Clin Endocrinol Metab. 2005 Jan;90(1):135-41
references: 15522938
references: J Clin Endocrinol Metab. 2007 Oct;92(10):3803-8
references: 17666472
references: World J Surg. 2007 Jun;31(6):1202-9
references: 17460812
references: Am J Med. 1998 Feb;104(2):115-22
references: 9528728
references: JAMA Surg. 2013 Feb;148(2):109-15
references: 23560281
references: J Clin Endocrinol Metab. 2009 Feb;94(2):373-81
references: 19193912
references: J Clin Endocrinol Metab. 1996 Jun;81(6):2036-40
references: 8964825
references: J Pharmacol Exp Ther. 2004 Feb;308(2):627-35
references: 14593085
references: Eur J Endocrinol. 2009 Jul;161(1):189-93
references: 19383807