Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
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ClinicalTrials.gov Identifier: NCT00120757 |
Recruitment Status
:
Completed
First Posted
: July 19, 2005
Last Update Posted
: December 22, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis HIV Infections | Drug: Alendronate | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | November 2008 |

- 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)
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120757
France | |
Service de Medecine Interne hopital Avicenne | |
Bobigny, France, 93009 cedex | |
Service de Rhumatologie hopital Pitie-Salpetriere | |
Paris, France, 75013 | |
Hôpital Necker service des Maladies Infectieuses | |
Paris, France, 75015 |
Principal Investigator: | Sylvie Rozenberg, MD | Hopital Pitie-Salpetriere Paris service de Rhumatologie | |
Study Chair: | Dominique Costagliola | Inserm U720 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00120757 History of Changes |
Other Study ID Numbers: |
2004-002002-30 ANRS120 Fosivir |
First Posted: | July 19, 2005 Key Record Dates |
Last Update Posted: | December 22, 2011 |
Last Verified: | December 2011 |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Osteoporosis |
Additional relevant MeSH terms:
HIV Infections Osteoporosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Alendronate Bone Density Conservation Agents Physiological Effects of Drugs |