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Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00120757
First received: July 11, 2005
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Osteoporosis HIV Infections | Drug: Alendronate | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
| Estimated Enrollment: | 140 |
| Study Start Date: | October 2004 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00120757
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120757
Locations
| 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 | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
| Principal Investigator: | Sylvie Rozenberg, MD | Hopital Pitie-Salpetriere Paris service de Rhumatologie |
| Study Chair: | Dominique Costagliola | Inserm U720 |
More Information
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 |
| Study First Received: | July 11, 2005 |
| Last Updated: | December 21, 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 Alendronate Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 24, 2017