Bone Mineral Density (BMD) in HIV Infection

NCT00146094 | Terminated

• 1 other identifier: 2860
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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

Conditions

Osteopenia; Osteoporosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  From enrollment to the end of follow-up at 2 years

Study Arms (2)

Treated patient

EXPERIMENTAL

Procedure: BMD Measurement; Drug: antiretrovirals

Not treated patient

NO INTERVENTION

Interventions

BMD Measurement PROCEDURE

Treated patient

antiretrovirals DRUG

Treated with antiretrovirals

Treated patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infected men, Caucasian, age \> 18 years, ARV-naïve

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (3)

Centre Hospitalier de Colmar

Colmar, 68021, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68070, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• Rey D, Treger M, Sibilia J, Priester M, Bernard-Henry C, Cheneau C, Javier RM. Bone mineral density changes after 2 years of ARV treatment, compared to naive HIV-1-infected patients not on HAART. Infect Dis (Lond). 2015 Feb;47(2):88-95. doi: 10.3109/00365548.2014.968610. Epub 2014 Nov 26.

  PMID: 25426996 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; HIV Infections

Interventions

Anti-Retroviral Agents

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antiviral Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• David REY, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: March 1, 2003
• Primary Completion: March 1, 2003
• Study Completion: December 14, 2006
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

FR (3)