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Bone Mineral Density (BMD) in HIV Infection

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ClinicalTrials.gov Identifier: NCT00146094
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : August 30, 2011
Information provided by:
University Hospital, Strasbourg, France

Brief Summary:

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 or disease Intervention/treatment
Osteopenia Osteoporosis Procedure: BMD Measurement

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Basic Science
Official Title: Osteopenia and Osteoporosis in HIV Infection. Prospective BMD Measurement in Antiretroviral (ARV) Treated and Untreated HIV-1 Infected Patients
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. BMD evolution and modification during 2 years of follow-up, compared between treated and untreated subjects

Secondary Outcome Measures :
  1. BMD (baseline, and at 2 years) according to:
  2. - calcium intake, physical activity,
  3. - CD4 lymphocyte count, HIV viral load,
  4. - bone metabolism biological markers (osteocalcine, C telopeptide collagen type I in urine),
  5. - leptine, parathormone, 25 OH D3

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146094

Centre Hospitalier de Colmar
Colmar, France, 68021
Centre Hospitalier de Mulhouse
Mulhouse, France, 68070
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: David REY, MD Hôpitaux Universitaires de Strasbourg

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00146094     History of Changes
Other Study ID Numbers: 2860
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by University Hospital, Strasbourg, France:
bone mineral density
HIV infection
bone metabolism
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Bone Diseases, Metabolic
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases