Evidence map›Paper›PMID 25637076›Full record

Trial reportEuropean journal of endocrinology2015

Cinacalcet normalizes serum calcium in a double-blind randomized, placebo-controlled study in patients with primary hyperparathyroidism with contraindications to surgery.

Aliya Khan, John Bilezikian, Henry Bone, Andrey Gurevich, Peter Lakatos, Waldemar Misiorowski, Liudmila Rozhinskaya, Marie-Louise Trotman, Miklós Tóth

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of endocrinology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00975221 (A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00975221 phase3completednot on this map

A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinacalcet for the Treatment of Hypercalcemia in Subjects With Primary Hyperparathyroidism Unable to Undergo Parathyroidectomy

TypeinterventionalSponsorAmgenRan2010 to 2012Enrolled67ConditionsHyperparathyroidism, Primary, HypercalcemiaArmsCinacalcet, Placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Review
  9. Bone Disease in Primary Hyperparathyroidism.Journal of musculoskeletal & neuronal interactions · 2025
    Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Medical management of primary hyperparathyroidism.Archives of endocrinology and metabolism · 2022
    Review
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Aliya KhanDivisions 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.
John BilezikianDivisions 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.
Henry BoneDivisions 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.
Andrey GurevichDivisions 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.
Peter LakatosDivisions 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.
Waldemar MisiorowskiDivisions 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.
Liudmila RozhinskayaDivisions 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.
Marie-Louise TrotmanDivisions 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.
Miklós TóthDivisions 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.
McMaster University Medical Centre · CA

Funding

PRIMARY HYPERPARATHYROIDISMR01DK032333 · NIDDK · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI BILEZIKIAN, JOHN P · 1986 to 2018
$9.6M
NIDDK NIH HHS R01 DK032333
6 · The paper itself

Abstract

objectivePrimary 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.

designPhase 3, double-blind, multi centere, randomized, placebo-controlled study.

methodsSixty-seven subjects (78% women) with moderate PHPT were randomized (1:1) to cinacalcet or placebo for ≤28 weeks.

main outcome measureAchievement of a normal mean corrected total serum calcium concentration of ≤10.3 mg/dl (2.575 mmol/l).

resultsBaseline 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.

conclusionsThese results demonstrate that cinacalcet normalizes serum calcium in this PHPT population and appears to be well tolerated.

Indexed as

ParathyroidectomyAdultAgedAged, 80 and overCinacalcetContraindicationsDouble-Blind MethodEndpoint DeterminationFemaleHumansHypercalcemiaHyperparathyroidismMaleMiddle AgedNaphthalenesPhosphorusCinacalcetNaphthalenesPhosphorus

Identifiers

PMID25637076
PMCPMC5729741
OpenAlexW2002519085

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.