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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
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Emmanuel LAVOUE, Directeur Adjoint, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00146094     History of Changes
Other Study ID Numbers: 2860
Study First Received: September 2, 2005
Last Updated: August 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Bone Diseases, Metabolic
Osteoporosis
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

ClinicalTrials.gov processed this record on May 16, 2013