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Clinical Trials

MainTitle

Bone Mineral Density (BMD) in HIV Infection

This study has been completed
Sponsor
University Hospital, Strasbourg, France


Information provided by (Responsible Party)
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

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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

More Information


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  

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

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.