Evidence map›Paper›PMID 29931143›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2018

Oxandrolone Treatment Results in an Increased Risk of Gonadarche in Prepubertal Boys With Klinefelter Syndrome.

Shanlee M Davis, Najiba Lahlou, Matthew Cox-Martin, Karen Kowal, Philip S Zeitler, Judith L Ross

Open access · bronzeAbstract readRandomized 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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.2field-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

9 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Attenuated androgen discontinuation in patients with hereditary angioedema: a commented case series.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2022
    Article
  3. Recent advancement in the treatment of boys and adolescents with hypogonadism.Therapeutic advances in endocrinology and metabolism · 2022
    Review
  4. Article
  5. Article
  6. Sex chromosome aneuploidies in 2020-The state of care and research in the world.American journal of medical genetics. Part C, Seminars in medical genetics · 2020
    Article
  7. Morbidity in Klinefelter syndrome and the effect of testosterone treatment.American journal of medical genetics. Part C, Seminars in medical genetics · 2020
    Review
  8. Effects of the Timing of Sex-Steroid Exposure in Adolescence on Adult Health Outcomes.The Journal of clinical endocrinology and metabolism · 2019
    Review
  9. Review
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 5 institutions in 2 countries.

Shanlee M DavisDepartment of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado.
Najiba LahlouHopital Cochin, Laboratoire d'Hormonologie, Paris, France.
Matthew Cox-MartinAdult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS) Program, University of Colorado School of Medicine, Aurora, Colorado.
Karen KowalDepartment of Pediatrics, Thomas Jefferson University, Philadelphia, Pennsylvania.
Philip S ZeitlerDepartment of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado.
Judith L RossDepartment of Pediatrics, Thomas Jefferson University, Philadelphia, Pennsylvania.
University of Colorado Denver · USAlfred I. duPont Hospital for Children · USDuPont (United States) · USHôpital Cochin · FROutcomes Research Consortium · US

Funding

PILOT STUDY--SUBSTRATE METABOLISM IN EXTREMELY LOW BIRTH WEIGHT INFANTSP30DK048520 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI Edward L Melanson · 1995 to 2026
$32.6M
Androgen effect on motor/cognitive outcome in Klinefelter syndromeR01NS050597 · NINDS · THOMAS JEFFERSON UNIVERSITY · PI ROSS, JUDITH L · 2006 to 2010
$4.1M
TESTO: Testosterone Effects on Short-Term Outcomes in Infants with XXYK23HD092588 · NICHD · UNIVERSITY OF COLORADO DENVER · PI DAVIS, SHANLEE · 2017 to 2021
$826k
NICHD NIH HHS K23 HD092588NINDS NIH HHS R01 NS050597
6 · The paper itself

Abstract

Context: Klinefelter syndrome (KS) is a common genetic condition in which males have an extra X chromosome. KS is associated with testosterone deficiency, neurodevelopmental delays, and cardiometabolic disorders. There has been recent interest in prepubertal androgen treatment; however, the effects on puberty and gonadal function are unknown. Objective: To compare onset of puberty and testicular function in prepubertal boys treated with 2 years of oxandrolone (Ox) vs placebo (Pl). Design: Double-blind, randomized, controlled trial. Setting: Single tertiary care referral center. Participants: Eighty prepubertal boys with KS; mean age: 8.0 ± 2.2 years (range: 4 to 12). Interventions: Ox 0.05 mg/kg vs identical-appearing Pl capsule given for 2 years. Outcome Measures: Onset of gonadarche (testicular volume ≥4 mL) and onset of pubarche (Tanner 2 pubic hair); change in testicular hormone concentrations. Results: Ox-treated group had 20.5 times higher odds of reaching gonadarche (OR 95% CI: 6.5, 77.8) and 28.1 times higher odds of reaching pubarche (OR 95% CI: 8.8, 110.4) during the 2-year study period after adjusting for baseline age. Gonadarche and pubarche both occurred at a younger age in the Ox group (gonadarche: 9.8 ± 1.5 vs 12.1 ± 1.0 years, P < 0.001; pubarche: 10.2 ± 1.1 vs 11.6 ± 1.3 years, P = 0.02). Serum concentrations of testicular hormones and gonadotropins were not different between groups. Conclusions: Two years of Ox treatment in prepubertal boys with KS results in an increased risk of early gonadarche, on average 2 years earlier than in Pl-treated boys. Ox did not affect serum concentrations of testicular hormones.

Indexed as

AndrogensChildChild, PreschoolDouble-Blind MethodHumansKlinefelter SyndromeMaleOxandrolonePubertyTesticular HormonesTestisTreatment OutcomeAndrogensOxandroloneTesticular Hormones

Identifiers

PMID29931143
PMCPMC6126887
OpenAlexW2808901132

What OpenQuestion holds

Textmetadata
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.