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Bone Mineral Density (BMD) in HIV Infection

Primary Purpose

Osteopenia, Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

BMD Measurement

About this trial

This is an interventional basic science trial for Osteopenia focused on measuring Osteopenia, osteoporosis, bone mineral density, HIV infection, bone metabolism, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier de Colmar
Centre Hospitalier de Mulhouse
Hôpitaux Universitaires de Strasbourg

Outcomes

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

Full Information

NCT ID

NCT00146094

First Posted

September 2, 2005

Last Updated

August 29, 2011

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT00146094

Brief Title

Bone Mineral Density (BMD) in HIV Infection

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia, Osteoporosis

Keywords

Osteopenia, osteoporosis, bone mineral density, HIV infection, bone metabolism, Treatment Naive

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

BMD Measurement

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

BMD (baseline, and at 2 years) according to:

Title

- calcium intake, physical activity,

Title

- CD4 lymphocyte count, HIV viral load,

Title

- bone metabolism biological markers (osteocalcine, C telopeptide collagen type I in urine),

Title

- leptine, parathormone, 25 OH D3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David REY, MD

Organizational Affiliation

Hôpitaux Universitaires de Strasbourg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier de Colmar

City

Colmar

ZIP/Postal Code

68021

Country

France

Facility Name

Centre Hospitalier de Mulhouse

City

Mulhouse

ZIP/Postal Code

68070

Country

France

Facility Name

Hôpitaux Universitaires de Strasbourg

City

Strasbourg

ZIP/Postal Code

67091

Country

France

12. IPD Sharing Statement

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Bone Mineral Density (BMD) in HIV Infection

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