Bone Mineral Density (BMD) in HIV Infection

Osteoporosis Clinical Trial

Official title:

Osteopenia and Osteoporosis in HIV Infection. Prospective BMD Measurement in Antiretroviral (ARV) Treated and Untreated HIV-1 Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146094
• Other study ID #: 2860
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: August 29, 2011
• Start date: March 2003

Study information

• Verified date: August 2011
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Osteopenia
• Osteoporosis

Intervention

Procedure:
• BMD Measurement

Locations

Country	Name	City	State
France	Centre Hospitalier de Colmar	Colmar
France	Centre Hospitalier de Mulhouse	Mulhouse
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMD evolution and modification during 2 years of follow-up, compared between treated and untreated subjects
Secondary	BMD (baseline, and at 2 years) according to:
Secondary	- calcium intake, physical activity,
Secondary	- CD4 lymphocyte count, HIV viral load,
Secondary	- bone metabolism biological markers (osteocalcine, C telopeptide collagen type I in urine),
Secondary	- leptine, parathormone, 25 OH D3