Evidence map›Paper›PMID 29099947›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2018

Recombinant Human Parathyroid Hormone Effect on Health-Related Quality of Life in Adults With Chronic Hypoparathyroidism.

Tamara J Vokes, Michael Mannstadt, Michael A Levine, Bart L Clarke, Peter Lakatos, Kristina Chen, Rebecca Piccolo, Alan Krasner, Dolores M Shoback, John P Bilezikian

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 4 pooled it
8.7field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 4 syntheses or guidelines pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. 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
  4. Parathyroid Allotransplantation: A Systematic Review.Medical sciences (Basel, Switzerland) · 2022
    Pooled it
  5. Trial
  6. Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2023
    Trial
  7. Trial
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Content validation of the SF-36v2® Health Survey Acute for use in hypoparathyroidism.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Article
  16. Management of Hypoparathyroidism.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022
    Article
  17. Observational
  18. Observational
  19. Article
  20. A Pilot Study of Cognition Among Hypoparathyroid Adults.Journal of the Endocrine Society · 2022
    Article
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

10 authors at 9 institutions in 2 countries.

Tamara J VokesSection of Endocrinology, University of Chicago Medicine, Chicago, Illinois.
Michael MannstadtEndocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Michael A LevineDivision of Endocrinology and Diabetes and Center for Bone Health, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Bart L ClarkeMayo Clinic Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Rochester, Minnesota.
Peter Lakatos1st Department of Medicine, Semmelweis University, Budapest, Hungary.
Kristina ChenShire Human Genetic Therapies, Inc., Lexington, Massachusetts.
Rebecca PiccoloShire Human Genetic Therapies, Inc., Lexington, Massachusetts.
Alan KrasnerShire Human Genetic Therapies, Inc., Lexington, Massachusetts.
Dolores M ShobackEndocrine Research Unit, SF Department of Veterans Affairs Medical Center, University of California, San Francisco, California.
John P BilezikianDivision of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.
Takeda (United States) · USChildren's Hospital of Philadelphia · USColumbia University · USMassachusetts General Hospital · USMayo Clinic · USResearch Institute for Genetic and Human Therapy · USSemmelweis University · HUUniversity of California, San Francisco · USUniversity of Chicago · US

Funding

The Role of GCM2 in Parathyroid Gland HomeostasisR01DK079970 · NIDDK · CHILDREN'S HOSP OF PHILADELPHIA · PI LEVINE, MICHAEL A. · 2009 to 2015
$3.2M
NIDDK NIH HHS R01 DK079970
6 · The paper itself

Abstract

Context: Reduced health-related quality of life (HRQoL) is common in patients with hypoparathyroidism treated conventionally with calcium and active vitamin D supplements. Objective: To examine the effects of recombinant human parathyroid hormone [rhPTH(1-84)] on HRQoL as measured by the 36-Item Short-Form Health Survey (SF-36) during a multinational, randomized, placebo-controlled study. Patients: Adults (N = 122) with chronic hypoparathyroidism. Intervention(s): After an optimization period when calcium and/or active vitamin D supplements were adjusted to reach target serum calcium levels (8.0 to 9.0 mg/dL; 2.0 to 2.2 mmol/L), patients were randomly assigned to receive placebo (n = 39) or rhPTH(1-84) (n = 83) (starting dose, 50 μg/d, could be titrated up to 100 μg/d); supplement doses were adjusted to maintain target serum calcium levels. Main Outcome Measure(s): Change from baseline (postoptimization, at randomization) to week 24 in HRQoL as assessed by the SF-36. Results: Overall, the between-group differences were not statistically significant. However, in the rhPTH(1-84) group, there were significant improvements in the physical component summary score (P = 0.004), and in body pain (P < 0.05), general health (P < 0.05), and vitality (P < 0.001) domains as compared with baseline values. In the placebo group, there were no significant changes for any domains. The magnitude of change between 0 and 24 weeks in SF-36 scores was negatively correlated with baseline scores, such that patients with lower HRQoL at baseline were more likely to experience improvement in response to treatment. Conclusion: Treatment with rhPTH(1-84) may improve HRQoL in adults with hypoparathyroidism.

Indexed as

Quality of LifeAdultAgedAged, 80 and overCalciumChronic DiseaseDouble-Blind MethodFemaleHealth StatusHormone Replacement TherapyHumansHypoparathyroidismMaleMiddle AgedParathyroid HormoneRecombinant ProteinsCalciumParathyroid HormonePTH protein, humanRecombinant ProteinsVitamin D

Identifiers

PMID29099947
PMCPMC6458961
OpenAlexW2766126031

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.