Evidence map›Paper›PMID 27734257›Full record

Trial reportEndocrine2017

Effects of parathyroid hormone rhPTH(1-84) on phosphate homeostasis and vitamin D metabolism in hypoparathyroidism: REPLACE phase 3 study.

Bart L Clarke, Tamara J Vokes, John P Bilezikian, Dolores M Shoback, Hjalmar Lagast, Michael Mannstadt

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Endocrine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
6.0field-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.

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

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Guideline
  2. 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
  3. Trial
  4. Review
  5. A novel mutation in exon 18 ofThe Journal of international medical research · 2026
    Article
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  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
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  15. Observational
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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

6 authors at 6 institutions in 1 country.

Bart L ClarkeDivision of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, E18-A, 200 1st Street SW, Rochester, MN, 55905, USA. clarke.bart@mayo.edu.ORCID http://orcid.org/0000-0002-3801-9546
Tamara J VokesSection of Endocrinology, University of Chicago Medicine, 5841 South Maryland Avenue, MC1027, Chicago, IL, 60637, USA.
John P BilezikianDivision of Endocrinology, College of Physicians and Surgeons, Columbia University, 630 W 168th Street, Room 864, New York, NY, 10032, USA.
Dolores M ShobackEndocrine Research Unit, San Francisco Department of Veterans Affairs Medical Center, University of California, 1700 Owens Street, San Francisco, CA, 94158, USA.
Hjalmar LagastNPS Pharmaceuticals, Inc., 300 Shire Way, Lexington, MA, 02421, USA.
Michael MannstadtEndocrine Unit, Massachusetts General Hospital and Harvard Medical School, 50 Blossom Street, Thier-1123, Boston, MA, 02114, USA.
Columbia University · USHarvard University · USMayo Clinic · USSan Francisco VA Medical Center · USTakeda (United States) · USUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In hypoparathyroidism, inappropriately low levels of parathyroid hormone lead to unbalanced mineral homeostasis. The objective of this study was to determine the effect of recombinant human parathyroid hormone, rhPTH(1-84), on phosphate and vitamin D metabolite levels in patients with hypoparathyroidism. Following pretreatment optimization of calcium and vitamin D doses, 124 patients in a phase III, 24-week, randomized, double-blind, placebo-controlled study of adults with hypoparathyroidism received subcutaneous injections of placebo or rhPTH(1-84) (50 µg/day, titrated to 75 and then 100 µg/day, to permit reductions in oral calcium and active vitamin D doses while maintaining serum calcium within 2.0-2.2 mmol/L). Predefined endpoints related to phosphate homeostasis and vitamin D metabolism were analyzed. Serum phosphate levels decreased rapidly from the upper normal range and remained lower with rhPTH(1-84) (P < 0.001 vs. placebo). At week 24, serum calcium-phosphate product was lower with rhPTH(1-84) vs. placebo (P < 0.001). rhPTH(1-84) treatment resulted in significant reductions in oral calcium dose compared with placebo (P < 0.001) while maintaining serum calcium. After pretreatment optimization, baseline serum 25-hydroxyvitamin D (25[OH]D) and 1,25-dihydroxyvitamin D (1,25[OH]

Indexed as

AdultCalciumDouble-Blind MethodFemaleHomeostasisHormone Replacement TherapyHumansHypoparathyroidismMaleMiddle AgedParathyroid HormonePhosphatesRecombinant ProteinsTreatment OutcomeVitamin DCalciumParathyroid HormonePhosphatesRecombinant ProteinsVitamin DHypoparathyroidismParathyroid hormonePhosphaterhPTH(1–84)Vitamin D

Identifiers

PMID27734257
PMCPMC5225224
OpenAlexW2530780656

What OpenQuestion holds

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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.