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Bone Mineral Density (BMD) in HIV Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00146094
First Posted: September 5, 2005
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Strasbourg, France
  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 Intervention
Osteopenia Osteoporosis Procedure: BMD Measurement

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

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

Secondary Outcome Measures:
  • 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

Study Start Date: March 2003
  Eligibility

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


Locations
France
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
Investigators
Principal Investigator: David REY, MD Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00146094     History of Changes
Other Study ID Numbers: 2860
First Submitted: September 2, 2005
First Posted: September 5, 2005
Last Update Posted: August 30, 2011
Last Verified: August 2011

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

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Osteoporosis
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