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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002002-30 | EudraCT Number |
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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.
The purposes of this trial are:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Rozenberg, MD | Hopital Pitie-Salpetriere Paris service de Rhumatologie | Principal Investigator |
| Dominique Costagliola | Inserm U720 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Medecine Interne hopital Avicenne | Bobigny | 93009 cedex | France | |||
| Service de Rhumatologie hopital Pitie-Salpetriere |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22353022 | Derived | 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. |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| 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 |
| Paris |
| 75013 |
| France |
| Hôpital Necker service des Maladies Infectieuses | Paris | 75015 | France |
| D009750 |
| Nutritional and Metabolic Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |