OsteopeniaNCT00146094
Bone Mineral Density (BMD) in HIV Infection
A study testing BMD Measurement and antiretrovirals in people with Osteopenia and Osteoporosis, run by University Hospital, Strasbourg, France at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- BMD Measurement and antiretrovirals
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2003to 14 Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected men, Caucasian, age > 18 years, ARV-naïve
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier de Colmar
Colmar, 68021
Centre Hospitalier de Mulhouse
Mulhouse, 68070
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Osteopenia and Osteoporosis in HIV Infection. Prospective BMD Measurement in Antiretroviral (ARV) Treated and Untreated HIV-1 Infected Patients
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
- Being tested
- BMD Measurement, antiretrovirals
- Keywords
- Osteopenia, osteoporosis, bone mineral density, HIV infection, bone metabolism, Treatment Naive
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMD MeasurementProcedure or surgery
antiretroviralsDrug
Treated with antiretrovirals
| Study group | Role | What they receive |
|---|---|---|
| Treated patient | Experimental | Not described Receives: Procedure: BMD Measurement; Drug: antiretrovirals |
| Not treated patient | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD evolution and modification during 2 years of follow-up, compared between treated and untreated subjects
Measured: From enrollment to the end of follow-up at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionMar 2003
- Study completion14 Dec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David REY, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146094
- Sponsor's protocol ID
- 2860
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2005
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25426996
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopenia and Osteoporosis in HIV Infection. Prospective BMD Measurement in Antiretroviral (ARV) Treated and Untreated HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00146094
- Acronym / sponsor ID
- 2860
- Conditions
- Osteopenia, Osteoporosis
- Keywords
- Osteopenia, osteoporosis, bone mineral density, HIV infection, bone metabolism, Treatment Naive
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Mar 2003 (actual)
- Primary completion
- Mar 2003 (actual)
- Study completion
- 14 Dec 2006 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated patient | Experimental | Procedure: BMD Measurement, Drug: antiretrovirals |
| Not treated patient | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-1 infected men, Caucasian, age > 18 years, ARV-naïve
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMD Measurement | Procedure or surgery | Treated patient |
| antiretroviralsTreated with antiretrovirals | Drug | Treated patient |
Primary outcome
BMD evolution and modification during 2 years of follow-up, compared between treated and untreated subjects
Time frame: From enrollment to the end of follow-up at 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 25426996Rey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David REY, MD principal investigator
Hôpitaux Universitaires de Strasbourg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMD Measurement and antiretrovirals in people with Osteopenia and Osteoporosis, run by University Hospital, Strasbourg, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD evolution and modification during 2 years of follow-up, compared between treated and untreated subjects (time frame: From enrollment to the end of follow-up at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00146094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.