Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 10:57 PM
Study NCT ID:
NCT00120757
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2005-07-11', 'studyFirstSubmitQcDate': '2005-07-18', 'lastUpdatePostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}], 'secondaryOutcomes': [{'measure': 'Percentage of variation of femoral T-score between M0 and M24'}, {'measure': 'Percentages of variation of lumbar and femoral T score between M0 and M12'}, {'measure': 'Evolution of bone metabolism markers'}, {'measure': 'Occurrence of fractures'}, {'measure': 'Tolerance of alendronate'}, {'measure': 'Measure of the prevalence of osteopenia and osteoporosis in HIV-infected men and women'}, {'measure': '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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoporosis'], 'conditions': ['Osteoporosis', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '22353022', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The purposes of this trial are:\n\n* To study the efficacy of alendronate in HIV-associated osteoporosis\n* 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant\n* Non menopausal women\n* 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%)\n* HIV infection known for at least 5 years\n* CD4 cell count over 50/mm3\n* Karnofsky score over or equal to 70\n* Written informed consent.\n\nExclusion Criteria:\n\n* 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\n* Testosterone below normal if treatment is hormonal\n* BMI below or equal to 18\n* Severe lung failure\n* Chronic alcohol intoxication\n* Ongoing opportunistic infection\n* Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months\n* History of treatment for osteoporosis\n* History of malignancy in the previous 5 years (except skin cancer and Kaposi)\n* Cytotoxic chemotherapy or cytokine therapy\n* Liver cirrhosis\n* Breast feeding'}, 'identificationModule': {'nctId': 'NCT00120757', 'briefTitle': 'Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Efficacy of Alendronate Versus Placebo in the Treatment of HIV-1 Associated Osteoporosis, a Multicenter, Randomized, Controlled Trial. ANRS 120 Fosivir', 'orgStudyIdInfo': {'id': '2004-002002-30'}, 'secondaryIdInfos': [{'id': 'ANRS120 Fosivir'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Alendronate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93009 cedex', 'city': 'Bobigny', 'country': 'France', 'facility': 'Service de Medecine Interne hopital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Service de Rhumatologie hopital Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker service des Maladies Infectieuses', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Sylvie Rozenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Pitie-Salpetriere Paris service de Rhumatologie'}, {'name': 'Dominique Costagliola', 'role': 'STUDY_CHAIR', 'affiliation': 'Inserm U720'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}