Bone Mineral Density (BMD) in HIV Infection

Not Applicable

Completed

• Conditions: Osteopenia; Osteoporosis

• Registration Number: NCT00146094
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMD evolution and modification during 2 years of follow-up, compared between treated and untreated subjects

Secondary Outcome Measures

Name	Time	Method
- calcium intake, physical activity,
- CD4 lymphocyte count, HIV viral load,
BMD (baseline, and at 2 years) according to:
- bone metabolism biological markers (osteocalcine, C telopeptide collagen type I in urine),
- leptine, parathormone, 25 OH D3

Trial Locations

Locations (3)

Centre Hospitalier de Colmar; 🇫🇷 Colmar, France

Centre Hospitalier de Mulhouse; 🇫🇷 Mulhouse, France

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France