Bone Mineral Density (BMD) in HIV Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-12-14

Brief Summary

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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

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Detailed Description

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Conditions

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Osteopenia Osteoporosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Treated patient

Group Type EXPERIMENTAL

BMD Measurement

Intervention Type PROCEDURE

antiretrovirals

Intervention Type DRUG

Treated with antiretrovirals

Not treated patient

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BMD Measurement

Intervention Type PROCEDURE

antiretrovirals

Treated with antiretrovirals

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No