Evidence map›Paper›PMID 33735389›Full record

ArticleThe Journal of clinical endocrinology and metabolism2021

Testosterone Therapy Effects on Bone Mass and Turnover in Hypogonadal Men with Type 2 Diabetes.

Georgia Colleluori, Lina Aguirre, Nicola Napoli, Clifford Qualls, Dennis T Villareal, Reina Armamento-Villareal

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in The Journal of clinical endocrinology and metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01378299 (CYP19A1 Gene and Pharmacogenetics of Response), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
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.

NCT01378299 phase1completednot on this map

CYP19A1 Gene and Pharmacogenetics of Response

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2011 to 2017Enrolled105ConditionsHypogonadismArmsTestosterone Cypionate
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Bone quality in endocrine diseases: determinants and clinical relevance.Journal of endocrinological investigation · 2023
    Review
  7. Review
  8. Review
  9. The Roles of Androgens in Humans: Biology, Metabolic Regulation and Health.International journal of molecular sciences · 2022
    Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. 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

6 authors at 4 institutions in 2 countries.

Georgia ColleluoriDivision of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston 77030, TX, USA.ORCID 0000-0002-4908-9873
Lina AguirreNew Mexico VA Health Care System, Albuquerque, NM 87108, USA.
Nicola NapoliDepartment of Endocrinology and Diabetes, Campus Biomedico University, Via Alvaro del Portillo Rome, Italy.
Clifford QuallsDivision of Mathematics and Statistics, University of New Mexico School of Medicine, Albuquerque, NM 87108, USA.
Dennis T VillarealDivision of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston 77030, TX, USA.
Reina Armamento-VillarealDivision of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston 77030, TX, USA.ORCID 0000-0002-5956-4922
Michael E. DeBakey VA Medical Center · USNew Mexico VA Health Care System · USUniversità Campus Bio-Medico · ITUniversity of New Mexico · US

Funding

Aromatase Inhibitors and Weight Loss in Severely Obese Men with HypogonadismR01HD093047 · NICHD · BAYLOR COLLEGE OF MEDICINE · PI VILLAREAL, REINA C · 2017 to 2022
$1.9M
CSRD VA I01 CX001665NICHD NIH HHS R01 HD093047
6 · The paper itself

Abstract

contextMale hypogonadism is associated with low bone mineral density (BMD) and increased fragility fracture risk. Patients with type 2 diabetes (T2D) have relatively higher BMD, but greater fracture risk.

objectiveEvaluate the skeletal response to testosterone therapy in hypogonadal men with T2D compared with hypogonadal men without T2D.

methodsSingle arm, open-label clinical trial (NCT01378299) involving 105 men (40-74 years old), with average morning testosterone <300 ng/dL. Subjects were injected intramuscularly with testosterone cypionate (200 mg) every 2 weeks for 18 months. Testosterone and estradiol were assessed by liquid chromatography/mass spectrometry; serum C-terminal telopeptide of type I collagen (CTX), osteocalcin and sclerostin by enzyme-linked immunosorbent assay; glycated hemoglobin (HbA1c) by high-performance liquid chromatography, areal BMD (aBMD) and body composition by dual-energy x-ray absorptiometry; tibial volumetric BMD (vBMD) and bone geometry by peripheral quantitative computed tomography.

resultsAmong our population of hypogonadal men, 49 had T2D and 56 were non-T2D. After 18 months of testosterone therapy, there were no differences in circulating testosterone and estradiol between the groups. Hypogonadal men with T2D had increased osteocalcin, reflecting increased osteoblast activity, compared with non-T2D men (P < .01). T2D men increased lumbar spine aBMD (P < .05), total area at 38% tibia (P < .01) and periosteal and endosteal circumferences at the same site (P < .01 for both). T2D men had reduced tibial vBMD (P < .01), but preserved bone mineral content (P = .01). Changes in HbA1c or body composition were similar between the 2 groups.

conclusionTestosterone therapy results in greater improvements in the skeletal health of hypogonadal men with T2D than their nondiabetic counterparts.

Indexed as

Absorptiometry, PhotonAgedBone DensityBone RemodelingDiabetes Mellitus, Type 2Hormone Replacement TherapyHumansHypogonadismMaleMiddle AgedTestosteroneTibiaTestosteronetestosterone 17 beta-cypionatebone geometrybone mineral densityhypogonadismtestosteroneType 2 diabetes

Identifiers

PMID33735389
PMCPMC8599870
OpenAlexW3139139580

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.