Bone Mineral Density (BMD) in HIV Infection | NCT00146094

Studies
Bone Mineral Density (BMD) in HIV Infection

NCT00146094

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Sep 26, 2025Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Osteopenia
Osteoporosis

Interventions

BMD Measurement
antiretrovirals

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003Actual

Primary Completion Date

Mar 2003Actual

Completion Date

Dec 14, 2006Actual

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2025

Last Update Posted Date

Sep 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treated patient	Experimental		Procedure: BMD Measurement Drug: antiretrovirals
Not treated patient	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMD Measurement	Procedure		Treated patient
antiretrovirals

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David REY, MD	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de Colmar		Colmar		68021	France
Centre Hospitalier de Mulhouse

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25426996	Background	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.

ID	Term
D001851	Bone Diseases, Metabolic
D010024	Osteoporosis
D015658	HIV Infections

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000998	Antiviral Agents
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions