Evidence map›Paper›PMID 23162103›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2013

Therapy of hypoparathyroidism with PTH(1-84): a prospective four-year investigation of efficacy and safety.

Natalie E Cusano, Mishaela R Rubin, Donald J McMahon, Chiyuan Zhang, Rebecca Ives, Amanda Tulley, James Sliney, Serge C Cremers, John P Bilezikian

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01199614 (HEXT), which is not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
11.8field-weighted citation impact, top 1% 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.

NCT01199614 phase3completednot on this map

HEXT: The Hypoparathyroidism Studies, EXTended: The Effect of PTH on the Skeleton in Hypoparathyroidism

TypeinterventionalSponsorColumbia UniversityRan2009 to 2017Enrolled62ConditionsHypoparathyroidismArmsopen-label PTH(1-84)
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 193 citations in OpenAlex.

  1. Safety and Efficacy of PTH 1-34 and 1-84 Therapy in Chronic Hypoparathyroidism: A Meta-Analysis of Prospective Trials.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022
    Pooled it
  2. Impact of recombinant PTH on management of hypoparathyroidism: a systematic review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2016
    Pooled it
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  6. Safety and Efficacy of Oral Human Parathyroid Hormone (1-34) in Hypoparathyroidism: An Open-Label Study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2021
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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.

Natalie E CusanoDepartment of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York 10032, USA.
Mishaela R Rubin
Donald J McMahon
Chiyuan Zhang
Rebecca Ives
Amanda Tulley
James Sliney
Serge C Cremers
John P Bilezikian
Columbia University · US

Funding

BONE PROPERTIES IN HYPOPARATHYROIDISM: EFFECTS OF PTHR01DK069350 · NIDDK · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI BILEZIKIAN, JOHN P · 2005 to 2014
$6.1M
Skeletal Regulation of Cortical and Trabecular Bone by Parathyroid HormoneK23DK095944 · NIDDK · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI CUSANO, NATALIE · 2012 to 2016
$918k
NIDDK NIH HHS DK069350NIDDK NIH HHS DK095944NIDDK NIH HHS K23 DK095944NIDDK NIH HHS R01 DK069350PHS HHS 002525
6 · The paper itself

Abstract

contextPTH may be an effective treatment option for hypoparathyroidism, but long-term data are not available.

objectiveWe studied the effect of 4 yr of PTH(1-84) treatment in hypoparathyroidism.

designTwenty-seven subjects were treated with PTH(1-84) for 4 yr, with prospective monitoring of calcium and vitamin D requirements, serum and urinary calcium, serum phosphorus, bone turnover markers, and bone mineral density (BMD).

resultsTreatment with PTH(1-84) reduced supplemental calcium requirements by 37% (P = 0.006) and 1,25-dihydroxyvitamin D requirements by 45% (P = 0.008). Seven subjects (26%) were able to stop 1,25-dihydroxyvitamin D completely. Serum calcium concentration remained stable, and urinary calcium and phosphorus excretion fell. Lumbar spine BMD increased by 5.5 ± 9% at 4 yr (P < 0.0001). Femoral neck and total hip BMD remained stable. At 4 yr, distal radius BMD was not different from baseline. Bone turnover markers increased significantly, reaching a 3-fold peak from baseline values at 6-12 months (P < 0.05 for all), subsequently declining to steady-state levels at 30 months. Hypercalcemia was uncommon (11 episodes in eight subjects over 4 yr; 1.9% of all values), with most episodes occurring within the first 6 months and resolving with adjustment of supplemental calcium and vitamin D.

conclusionsPTH(1-84) treatment of hypoparathyroidism for up to 4 yr maintains the serum calcium concentration, while significantly reducing supplemental calcium and 1,25-dihydroxyvitamin D requirements. Lumbar spine BMD increases without significant changes at other sites. These data provide support for the safety and efficacy of PTH(1-84) therapy in hypoparathyroidism for up to 4 yr.

Indexed as

AdultAgedCalciumFemaleFollow-Up StudiesHormone Replacement TherapyHumansHypoparathyroidismMaleMiddle AgedParathyroid HormoneProspective StudiesTime FactorsTreatment OutcomeVitamin D1,25-dihydroxyvitamin DCalciumParathyroid HormoneVitamin D

Identifiers

PMID23162103
PMCPMC3537109
OpenAlexW2051155551

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.