OsteoporosisPhase 3NCT00120757
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
A Phase 3 study testing Alendronate in people with Osteoporosis and HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis at 3 sites in France.
Trial summary
Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, HIV Infections
- What is being tested?
- Alendronate
- How many people
- 140 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2004to Nov 2008
- Phase
- Phase 3
- 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
- Non-pregnant
- Non menopausal women
- Total femur BMD below -2.5 SD (T score) or lumbar spine BMD below -2.5 SD (T score) or BMD below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%)
- HIV infection known for at least 5 years
- CD4 cell count over 50/mm3
- Karnofsky score over or equal to 70
- Written informed consent.
Who cannot join
- Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria
- Testosterone below normal if treatment is hormonal
- BMI below or equal to 18
- Severe lung failure
- Chronic alcohol intoxication
- Ongoing opportunistic infection
Show all 12Show fewer
- Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months
- History of treatment for osteoporosis
- History of malignancy in the previous 5 years (except skin cancer and Kaposi)
- Cytotoxic chemotherapy or cytokine therapy
- Liver cirrhosis
- Breast feeding
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Medecine Interne hopital Avicenne
Bobigny, 93009 cedex
Service de Rhumatologie hopital Pitie-Salpetriere
Paris, 75013
Hôpital Necker service des Maladies Infectieuses
Paris, 75015
About this study
Official title: Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir
Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.
Read the detailed description
The purposes of this trial are:
- To study the efficacy of alendronate in HIV-associated osteoporosis
- To measure the prevalence of osteoporosis in HIV patients and to detect risk factors in a large cohort of HIV patients from the screening phase
- Conditions
- Osteoporosis, HIV Infections
- Being tested
- Alendronate
- Keywords
- Osteoporosis
- Medical subject headings
- Osteoporosis, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of variation of lumbar BMD on DEXA scan at month 24 versus month 0 for patients included with lumbar osteoporosis (femoral for those included with only femoral osteoporosis)
Secondary outcomes (7)
Percentage of variation of femoral T-score between M0 and M24
Percentages of variation of lumbar and femoral T score between M0 and M12
Evolution of bone metabolism markers
Occurrence of fractures
Tolerance of alendronate
Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women
Description of the evolution of osteoporosis in HIV-infected men and women receiving calcium and vitamin D to define risk factors for osteoporosis in HIV-infected persons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2005 (estimated)
- Study startOct 2004
- Primary completionNov 2008
- Study completionNov 2008
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 OsteoporosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sylvie Rozenberg, MD, Principal investigator, Hopital Pitie-Salpetriere Paris service de RhumatologieDominique Costagliola, Study chair, Inserm U720
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120757
- Sponsor's protocol ID
- ANRS 120 Fosivir
- Other IDs
- 2004-002002-30, 2004
- Status last verified
- Dec 2011
- First submitted
- 11 Jul 2005
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rozenberg S, Lanoy E, Bentata M, Viard JP, Valantin MA, Missy P, Darasteanu I, Roux C, Kolta S, Costagliola D; ANRS 120 Fosivir Study Group. Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Res Hum Retroviruses. 2012 Sep;28(9):972-80. doi: 10.1089/AID.2011.0224. Epub 2012 Mar 23.
PubMed 22353022
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir
- ClinicalTrials.gov ID
- NCT00120757
- Acronym / sponsor ID
- ANRS 120 Fosivir
- Conditions
- Osteoporosis, HIV Infections
- Keywords
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Oct 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Jul 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 being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.
Detailed description
The purposes of this trial are:
- To study the efficacy of alendronate in HIV-associated osteoporosis
- To measure the prevalence of osteoporosis in HIV patients and to detect risk factors in a large cohort of HIV patients from the screening phase
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-pregnant
- Non menopausal women
- Total femur BMD below -2.5 SD (T score) or lumbar spine BMD below -2.5 SD (T score) or BMD below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%)
- HIV infection known for at least 5 years
- CD4 cell count over 50/mm3
Key exclusion criteria (12 listed)
- Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria
- Testosterone below normal if treatment is hormonal
- BMI below or equal to 18
- Severe lung failure
- Chronic alcohol intoxication
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 |
|---|---|---|
| Alendronate | Drug | – |
Primary outcome
Percentage of variation of lumbar BMD on DEXA scan at month 24 versus month 0 for patients included with lumbar osteoporosis (femoral for those included with only femoral osteoporosis)
7 secondary outcomes
Percentage of variation of femoral T-score between M0 and M24
Percentages of variation of lumbar and femoral T score between M0 and M12
Evolution of bone metabolism markers
Occurrence of fractures
Tolerance of alendronate
Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women
Description of the evolution of osteoporosis in HIV-infected men and women receiving calcium and vitamin D to define risk factors for osteoporosis in HIV-infected persons
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 22353022Rozenberg S, Lanoy E, Bentata M, Viard JP, Valantin MA, Missy P, Darasteanu I, Roux C, Kolta S, Costagliola D; ANRS 120 Fosivir Study Group. Effect of alendronate on HIV-associated osteoporosis: a randomized, double-blind, placebo-controlled, 96-week trial (ANRS 120). AIDS Res Hum Retroviruses. 2012 Sep;28(9):972-80. doi: 10.1089/AID.2011.0224. Epub 2012 Mar 23.
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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.
Sylvie Rozenberg, MD principal investigator
Hopital Pitie-Salpetriere Paris service de Rhumatologie
Dominique Costagliola study chair
Inserm U720
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alendronate in people with Osteoporosis and HIV Infections, run by French National Agency for Research on AIDS and Viral Hepatitis 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 3 Apr 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of variation of lumbar BMD on DEXA scan at month 24 versus month 0 for patients included with lumbar osteoporosis (femoral for those included with only femoral osteoporosis). 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 NCT00120757, 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 3 Apr 2026.