Evidence map›Paper›PMID 33441362›Full record

ArticleBMJ open2021

PHILEOS (

Brigitte Tardy-Poncet, Barbara Play, Aurélie Montmartin, Pauline Damien, Edouard Ollier, Emilie Presles, Arnauld Garcin, Bernard Tardy

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04384341 (Haemophilia and Bone Loss PHILEOS Study), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 31% 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.

NCT04384341 nacompletednot on this map

Haemophilia and Bone Loss PHILEOS Study

TypeinterventionalSponsorCentre Hospitalier Universitaire de Saint EtienneRan2020 to 2024Enrolled448ConditionsHemophiliaArmsBone densitometry (BMD), Blood sampling for patients only
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Osteoporosis management and falls prevention in patients with haemophilia: Review of haemophilia guidelines.Haemophilia : the official journal of the World Federation of Hemophilia · 2022
    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

8 authors at 3 institutions in 1 country.

Brigitte Tardy-PoncetInserm CIC 1408, Saint-Etienne University Hospital Center, Saint-Etienne, Rhône-Alpes, France brigitte.tardy@chu-st-etienne.fr.ORCID 0000-0001-5409-942X
Barbara PlayRegional Medical Coagulation & Intensive Care, CSL Behring SA, Paris, Île-de-France, France.
Aurélie MontmartinInserm U1059, Sainbiose, University of Lyon, Saint-Etienne, Auvergne-Rhône-Alpes, France.
Pauline DamienInserm CIC 1408, Saint-Etienne University Hospital Center, Saint-Etienne, Rhône-Alpes, France.
Edouard OllierClinical Research Unit Innovation and Pharmacology, Saint-Etienne University Hospital Center, Saint-Etienne, Rhône-Alpes, France.
Emilie PreslesInserm CIC 1408, Saint-Etienne University Hospital Center, Saint-Etienne, Rhône-Alpes, France.
Arnauld GarcinClinical Research Unit Innovation and Pharmacology, Saint-Etienne University Hospital Center, Saint-Etienne, Rhône-Alpes, France.
Bernard TardyInserm CIC 1408, Saint-Etienne University Hospital Center, Saint-Etienne, Rhône-Alpes, France.
Université Claude Bernard Lyon 1 · FRCentre Hospitalier Universitaire de Saint-Étienne · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTwo meta-analyses showed lower bone mineral density (BMD) in patients with haemophilia (haemophilia type and severity were often not specified) compared with healthy controls. This finding could be related to reduced mobility and sedentary lifestyle, and/or hepatitis C or HIV infection. The aim of this study is to determine osteoporosis prevalence in patients with haemophilia classified in function of the disease type (A or B) and severity, and to evaluate the potential role of regular prophylactic factor replacement (early vs delayed initiation) in preserving or restoring BMD. METHODS AND ANALYSIS: The haemoPHILia and ostEoporOSis Study is a prospective, controlled, multicentre study that will include patients in France (13 haemophilia treatment centres), Belgium (1 centre) and Romania (1 centre). In total, 240 patients with haemophilia and 240 matched healthy controls will be recruited (1:1). The primary objective is to determine osteoporosis prevalence in patients with severe haemophilia A and B (HA and HB) without prophylaxis, compared with healthy controls. Secondary outcomes include: prevalence of osteoporosis and osteopenia in patients with mild, moderate and severe HA or HB with prophylaxis (grouped in function of their age at prophylaxis initiation), compared with healthy subjects; BMD in patients with HA and HB of comparable severity; correlation between BMD and basal factor VIII/IX levels and thrombin potential; and quantification of plasmatic markers of bone remodelling (formation and resorption) in patients with haemophilia. ETHICS AND DISSEMINATION: The protocol was approved by the French Ethics Committee and by the French National Agency for Medicines and Health Products Safety (number: 2019-A03358-49). The results of this study will be actively disseminated through scientific publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04384341.

Indexed as

Hemophilia AHIV InfectionsOsteoporosisBelgiumCase-Control StudiesFranceHumansMulticenter Studies as TopicProspective StudiesRomaniableeding disorders & coagulopathiesbone diseasesclinical trials

Identifiers

PMID33441362
PMCPMC7812091
OpenAlexW3120068890

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.