Evidence map›Paper›PMID 31369089›Full record

ArticleThe Journal of clinical endocrinology and metabolism2019

Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism.

Michael Mannstadt, Bart L Clarke, John P Bilezikian, Henry Bone, Douglas Denham, Michael A Levine, Munro Peacock, Jeffrey Rothman, Dolores M Shoback, Mark L Warren and 4 more

Open access · hybridAbstract read
In one paragraph

Article in The Journal of clinical endocrinology and metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 3 pooled it
8.4field-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

33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  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. Palopegteriparatide for adults with chronic hypoparathyroidism: skeletal dynamics through 3 years of the phase 2 PaTH forward trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2026
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. 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
  9. Trial
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Escherichia coli in the production of biopharmaceuticals.Biotechnology and applied biochemistry · 2025
    Review
  17. Review
  18. Article
  19. Article
  20. 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

14 authors at 12 institutions in 1 country.

Michael MannstadtEndocrine Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Bart L ClarkeDivision of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, Minnesota.
John P BilezikianDivision of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York.
Henry BoneMichigan Bone and Mineral Clinic, PC, Detroit, Michigan.
Douglas DenhamClinical Trials of Texas, Inc., San Antonio, Texas.
Michael A LevineDivision of Endocrinology and Diabetes and Center for Bone Health, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Munro PeacockDepartment of Medicine, Division of Endocrinology, Indiana University School of Medicine, Indianapolis, Indiana.
Jeffrey RothmanUniversity Physicians Group - Research Division, Staten Island, New York.
Dolores M ShobackEndocrine Research Unit, Department of Medicine, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, California.
Mark L WarrenEndocrinology and Metabolism, Physicians East, Greenville, North Carolina.
Nelson B WattsOsteoporosis and Bone Health Services, Mercy Health, Cincinnati, Ohio.
Hak-Myung LeeShire Human Genetic Therapies, Inc., a member of the Takeda group of companies, Lexington, Massachusetts.
Nicole SherryShire Human Genetic Therapies, Inc., a member of the Takeda group of companies, Cambridge, Massachusetts.
Tamara J VokesSection of Endocrinology, University of Chicago Medicine, Chicago, Illinois.
Takeda (United States) · USChildren's Hospital of Philadelphia · USClinical Trials of Texas · USColumbia University · USHarvard University · USIndiana University School of MedicineMayo Clinic · USMercy Health · USPhysicians East · USSan Francisco VA Medical Center · USUniversity of Chicago · USUniversity Physicians Group · US

Funding

CSRD VA I01 CX001514
6 · The paper itself

Abstract

contextConventional hypoparathyroidism treatment with oral calcium and active vitamin D is aimed at correcting hypocalcemia but does not address other physiologic defects caused by PTH deficiency.

objectiveTo evaluate long-term safety and tolerability of recombinant human PTH (1-84) [rhPTH(1-84)].

designOpen-label extension study; 5-year interim analysis.

setting12 US centers. PATIENTS: Adults (N = 49) with chronic hypoparathyroidism. INTERVENTION(S): rhPTH(1-84) 25 or 50 µg/d initially, with 25-µg adjustments permitted to a 100 µg/d maximum. MAIN OUTCOME MEASURE(S): Safety parameters; composite efficacy outcome was the proportion of patients with ≥50% reduction in oral calcium (or ≤500 mg/d) and calcitriol (or ≤0.25 µg/d) doses, and albumin-corrected serum calcium normalized or maintained compared with baseline, not exceeding upper limit of normal.

resultsForty patients completed 60 months of treatment. Mean albumin-corrected serum calcium levels remained between 8.2 and 8.7 mg/dL. Between baseline and month 60, levels ± SD of urinary calcium, serum phosphorus, and calcium-phosphorus product decreased by 101.2 ± 236.24 mg/24 hours, 1.0 ± 0.78 mg/dL, and 8.5 ± 8.29 mg2/dL2, respectively. Serum creatinine level and estimated glomerular filtration rate were unchanged. Treatment-emergent adverse events (AEs) were reported in 48 patients (98.0%; hypocalcemia, 36.7%; muscle spasms, 32.7%; paresthesia, 30.6%; sinusitis, 30.6%; nausea, 30.6%) and serious AEs in 13 (26.5%). At month 60, 28 patients (70.0%) achieved the composite efficacy outcome. Bone turnover markers increased, peaked at ∼12 months, and then declined to values that remained above baseline.

conclusionTreatment with rhPTH(1-84) for 5 years demonstrated a safety profile consistent with previous studies and improved key biochemical parameters.

Indexed as

AdultAgedCalcitriolCalciumCalcium, DietaryFemaleHormone Replacement TherapyHumansHypoparathyroidismMaleMiddle AgedParathyroid HormoneRecombinant ProteinsTreatment OutcomeCalcitriolCalciumCalcium, DietaryParathyroid HormoneRecombinant Proteins

Identifiers

PMID31369089
PMCPMC6760337
OpenAlexW2964710934

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.