Evidence map›Paper›PMID 22849962›Full record

Trial reportHIV clinical trials

Bone effects of rosiglitazone in HIV-infected patients with lipoatrophy.

Allison C Ross, Corrilynn O Hileman, Todd T Brown, Neal Fedarko, Norma Storer, Danielle Labbato, Grace A McComsey

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in HIV clinical trials. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Use of CTX-I and PINP as bone turnover markers: National Bone Health Alliance recommendations to standardize sample handling and patient preparation to reduce pre-analytical variability.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2017
    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

7 authors at 3 institutions in 1 country.

Allison C RossDepartment of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, Georgia 30322, USA. across3@emory.edu
Corrilynn O Hileman
Todd T Brown
Neal Fedarko
Norma Storer
Danielle Labbato
Grace A McComsey
Case Western Reserve University · USJohns Hopkins University · USChildren's Healthcare of Atlanta · US

Funding

Institute for Clinical and Translational Research (UL1)UL1RR025005 · NCRR · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2007 to 2011
$75.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Sharon L. Hillier, JONATHAN KARN · 1994 to 2026
$50.0M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Role of Mitochondria in HIV LipoatrophyR01AI060484 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2005 to 2009
$2.1M
Role of Mitochondria in HIV LipoatrophyR21AI060484 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2004 to 2004
$191k
NCATS NIH HHS UL1 TR000454NCRR NIH HHS 1UL1RR024989NCRR NIH HHS 5UL1RR025005-02NCRR NIH HHS UL1 RR024989NCRR NIH HHS UL1 RR025005NIAID NIH HHS AI-060484NIAID NIH HHS AI36219NIAID NIH HHS P30 AI036219NIAID NIH HHS R01 AI060484NIAID NIH HHS R21 AI060484
6 · The paper itself

Abstract

objectivesThiazoledinediones increase limb fat in HIV+ patients with lipoatrophy. However, their use in the general population has been associated with bone loss and fracture. We sought to determine the effects of rosiglitazone on bone metabolism in HIV-infected patients.

methodsHIV+ patients with lipoatrophy were randomized to rosiglitazone versus placebo for 48 weeks in a double-blind, placebo-controlled trial. Limb fat, bone mineral density (BMD), bone formation markers (procollagen type 1 amino-terminal propeptide [P1NP], osteocalcin [OC]) and bone resorption markers (C-terminal telopeptide of type I collagen [CTX]) were measured, along with receptor activator for nuclear factor kappa β ligand (RANKL), osteoprotegerin (OPG), and inflammatory cytokines.

resultsSeventy-one subjects were randomized to rosiglitazone or placebo: 17% female and 51% white. Total BMD did not change significantly in either group. In the rosiglitazone group, P1NP showed statistically significant decreases at 24 and 48 weeks; however, changes compared to placebo were only significant at 24 weeks. OC decreased significantly in the rosiglitazone group at 24 weeks, but there were no between-group differences. CTX, RANKL, or OPG did not change for either group. Multivariable regression within the rosiglitazone arm showed P1NP changes were inversely associated with limb fat changes, protease inhibitors, and tenofovir use.

conclusionRosiglitazone use was associated with decreased bone formation, but it did not alter bone resorption or total BMD. The increase in limb fat that accompanies rosiglitazone use appears to be associated with decreased osteoblast activity. Further studies are needed to determine the effect of thiazoledinediones on bone health in HIV-infected persons.

Indexed as

AdultBone and BonesBone DensityCollagen Type IDiabetes Mellitus, LipoatrophicDouble-Blind MethodFemaleHIV InfectionsHumansHypoglycemic AgentsMaleMiddle AgedMultivariate AnalysisOsteocalcinPeptidesRosiglitazoneCollagen Type Icollagen type I trimeric cross-linked peptideHypoglycemic AgentsOsteocalcinPeptidesRosiglitazoneThiazolidinediones

Identifiers

PMID22849962
PMCPMC3895474
OpenAlexW1982092017

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.