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Bone Mineral Density (BMD) in HIV Infection - Article


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Bone Density


Clinical Trial: Bone Mineral Density (BMD) in HIV Infection

This study is currently recruiting patients.
Verified by University of Strasbourg September 2005

Sponsored by: University of Strasbourg
Information provided by: University of Strasbourg
ClinicalTrials.gov Identifier: NCT00146094

Purpose

Osteopenia and osteoporosis are increasingly reported in HIV-infected patients, and appear to be more frequent than in general population. However, pathogenesis remains unclear, and published studies still give non concordant results.

We therefore started a prospective study, to assess the potential role of ARV in the occurrence of osteopenia and osteoporosis. BMD evolution over a 2-years period of follow-up, will be compared between patients starting ARV therapy, and subjects without HAART (no indication of treatment). A correlation between BMD and several factors will be looked at (see below).

This study with individual direct benefice, is conducted in 3 outpatients clinics (Strasbourg, Colmar, Mulhouse) in collaboration with the rheumatologic teams. 60 patients are planned to be included over a 3-years inclusion period

Condition
Osteopenia
Osteoporosis

MedlinePlus related topics:  Bone Diseases;   Osteoporosis

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Osteopenia and Osteoporosis in HIV Infection. Prospective BMD Measurement in Antiretroviral (ARV) Treated and Untreated HIV-1 Infected Patients

Further Study Details: 

Expected Total Enrollment:  60

Study start: March 2003

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • HIV-1 infected men, Caucasian, age > 18 years, ARV-naïve

Exclusion Criteria:

  • HIV-infected women, subjects < 18 years, non-Caucasian men, ARV-experienced patients, subjects not able or willing to give informed consent, endocrine disease or treatment which could affect bone metabolism

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00146094

David Rey, MD      33388117755    david.rey@chru-strasbourg.fr

France
      Hôpitaux Universitaires de Strasbourg, Strasbourg,  67091,  France; Recruiting
David Rey, MD  33388117755    david.rey@chru-strasbourg.fr 
David Rey, MD,  Principal Investigator
Jean Sibilia, MD,  Sub-Investigator
Javier Rose-Marie, MD,  Sub-Investigator
Catherine Roy, MD,  Sub-Investigator

      Centre Hospitalier de Colmar, Colmar,  68021,  France; Recruiting
Nathalie Plaisance, MD
Nathalie Plaisance, MD,  Principal Investigator
Hervé Dettloff, MD,  Sub-Investigator

      Centre Hospitalier de Mulhouse, Mulhouse,  68070,  France; Recruiting
Catherine Michel, MD
Catherine Michel, MD,  Principal Investigator
Geneviève Beck-Wirth, MD,  Sub-Investigator
Olivier Bonidan, MD,  Sub-Investigator
Catherine Turnani, MD,  Sub-Investigator

Study chairs or principal investigators

David REY, MD,  Principal Investigator,  Hôpitaux Universitaires de Strasbourg   

More Information

Study ID Numbers:  2860
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00146094
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-06


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September 5, 2008



Page Updated: October 3, 2005
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