Bone Mineral Density (BMD) in HIV Infection

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00146094
First received: September 2, 2005
Last updated: August 29, 2011
Last verified: August 2011

September 2, 2005
August 29, 2011
March 2003
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BMD evolution and modification during 2 years of follow-up, compared between treated and untreated subjects
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Complete list of historical versions of study NCT00146094 on ClinicalTrials.gov Archive Site
  • BMD (baseline, and at 2 years) according to:
  • - calcium intake, physical activity,
  • - CD4 lymphocyte count, HIV viral load,
  • - bone metabolism biological markers (osteocalcine, C telopeptide collagen type I in urine),
  • - leptine, parathormone, 25 OH D3
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Bone Mineral Density (BMD) in HIV Infection
Osteopenia and Osteoporosis in HIV Infection. Prospective BMD Measurement in Antiretroviral (ARV) Treated and Untreated HIV-1 Infected Patients

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

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Interventional
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Primary Purpose: Basic Science
  • Osteopenia
  • Osteoporosis
Procedure: BMD Measurement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00146094
2860
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Emmanuel LAVOUE, Directeur Adjoint, University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
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Principal Investigator: David REY, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP