Evidence map›Paper›PMID 25676588›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2015

Randomized, double-blind, dose-escalation trial of triptorelin for ovary protection in childhood-onset systemic lupus erythematosus.

Hermine I Brunner, Clovis A Silva, Andreas Reiff, Gloria C Higgins, Lisa Imundo, Calvin B Williams, Carol A Wallace, Nadia E Aikawa, Shannen Nelson, Marisa S Klein-Gitelman and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Article
  4. Do we really need cyclophosphamide for lupus nephritis?Pediatric nephrology (Berlin, Germany) · 2024
    Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. Menopause and Rheumatic Disease.Rheumatic diseases clinics of North America · 2017
    Review
  10. Review
  11. Gonadotropin ratio affects the in vitro growth of rhesus ovarian preantral follicles.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2016
    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

11 authors at 9 institutions in 2 countries.

Hermine I BrunnerCincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.
Clovis A Silva
Andreas Reiff
Gloria C Higgins
Lisa Imundo
Calvin B Williams
Carol A Wallace
Nadia E Aikawa
Shannen Nelson
Marisa S Klein-Gitelman
Susan R Rose
Cincinnati Children's Hospital Medical Center · USHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRMedical College of Wisconsin · USNationwide Children's Hospital · USNewYork–Presbyterian Hospital · USNorthwestern University · USSeattle Children's Hospital · USUniversity of Cincinnati · USUniversity of Southern California · US

Funding

VITAMIN K DEFICIENCY IN CHOLESTATIC LIVER DISEASEM01RR008084 · NCRR · CINCINNATI CHILDRENS HOSP MED CTR · PI HEUBI, JAMES E. · 1994 to 2009
$20.6M
Cincinnati Center for Clinical and Translational Sciences and TrainingUL1TR000077 · NCATS · UNIVERSITY OF CINCINNATI · PI HEUBI, JAMES E. · 2012 to 2014
$9.9M
NCATS NIH HHS UL1 TR000077NCATS NIH HHS UL-1-TR-00077NCRR NIH HHS M01 RR008084PHS HHS FDA-R-00-2369
6 · The paper itself

Abstract

objectiveTo determine the dose of triptorelin that is sufficient to maintain complete ovarian suppression in female patients with childhood-onset systemic lupus erythematosus (SLE) who require cyclophosphamide therapy, to determine the length of time needed to achieve ovarian suppression after initiation of triptorelin treatment, and to investigate the safety of triptorelin.

methodsIn this randomized, double-blind, placebo-controlled, dose-escalation study, female patients ages <21 years were randomized 4:1 to receive triptorelin (n = 25) or placebo (n = 6). The starting doses of triptorelin were 25, 50, 75, and 100 μg/kg, and the dose was escalated until complete ovarian suppression was maintained. The primary outcome was the weight-adjusted dose of triptorelin that provided complete ovarian suppression in at least 90% of the patients, as determined by gonadotropin-releasing hormone agonist stimulation testing. The secondary outcome was the period of time required to achieve ovarian suppression, as measured by unstimulated follicle-stimulating hormone and luteinizing hormone levels after the initiation of triptorelin treatment.

resultsTreatment with triptorelin at a weight-adjusted dose of 120 μg/kg body weight provided sustained complete ovarian suppression in 90% of the patients. After administration of the initial dose of triptorelin, 22 days were required to achieve complete ovarian suppression. The rates of adverse events (AEs) and serious adverse events (SAEs) per 100 patient-months of followup were not higher in the triptorelin group compared with the placebo group (for AEs, 189 versus 362; for SAEs, 2.1 versus 8.5).

conclusionHigh doses of triptorelin are needed to achieve and maintain complete ovarian suppression, but such doses appear to be well tolerated in adolescent female patients with childhood-onset SLE. Our data suggest that a lag time of 22 days after initiation of triptorelin treatment is required before cyclophosphamide therapy is started or continued.

Indexed as

Ovulation InhibitionAdolescentAntirheumatic AgentsCyclophosphamideDouble-Blind MethodFemaleFollicle Stimulating HormoneHumansLupus Erythematosus, SystemicLuteinizing HormoneLuteolytic AgentsPrimary Ovarian InsufficiencyTime FactorsTriptorelin PamoateYoung AdultAntirheumatic AgentsCyclophosphamideFollicle Stimulating HormoneLuteinizing HormoneLuteolytic AgentsTriptorelin Pamoate

Identifiers

PMID25676588
PMCPMC4414812
OpenAlexW1601194259

What OpenQuestion holds

Textmetadata
LicenceTDM
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.