CClinicalTrials.gg
Sign In
CompletedNCT00120757Updated Apr 3, 2026

Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)

A Phase 3 interventional study of Alendronate in Osteoporosis and HIV Infections, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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
02

Conditions studied

  • Osteoporosis
  • HIV Infections

Keywords

  • Osteoporosis
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 140 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 83 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
140 participants

Interventions

  • DrugAlendronate
06

What researchers measure

Primary outcomes

  1. 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

  1. Percentage of variation of femoral T-score between M0 and M24

  2. Percentages of variation of lumbar and femoral T score between M0 and M12

  3. Evolution of bone metabolism markers

  4. Occurrence of fractures

  5. Tolerance of alendronate

  6. Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women

  7. 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

07

Study locations

3 sites
  • Service de Medecine Interne hopital Avicenne
    Bobigny, 93009 cedex, France
  • Service de Rhumatologie hopital Pitie-Salpetriere
    Paris, 75013, France
  • Hôpital Necker service des Maladies Infectieuses
    Paris, 75015, France
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00120757
Lead sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Responsible party
Sponsor
First posted
Jul 19, 2005
Start date
Oct 2004
Primary completion
Nov 2008
Completion
Nov 2008
Last update
Apr 3, 2026

Study contacts

Sylvie Rozenberg, MD
principal investigator · Hopital Pitie-Salpetriere Paris service de Rhumatologie
Dominique Costagliola
study chair · Inserm U720

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoporosis→

Other studies from this sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Start the discussion