{"doc_desc":{"title":"Etude transversale sur des femmes m\u00e9nopaus\u00e9es : d\u00e9termination du pourcentage de patientes ost\u00e9oporotiques par mesure de la densit\u00e9 min\u00e9rale osseuse \u00e0 vis\u00e9e diagnostique","idno":"FRESH-PEF68-fr","producers":[{"name":"B\u00e9atrice AUGENDRE-FERRANTE","affiliation":"LILLY FRANCE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF68-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"68"},{"agency":"FReSH","code":"FRESH-PEF68"}]},"title":"Etude transversale sur des femmes m\u00e9nopaus\u00e9es : d\u00e9termination du pourcentage de patientes ost\u00e9oporotiques par mesure de la densit\u00e9 min\u00e9rale osseuse \u00e0 vis\u00e9e diagnostique","alternate_title":"PRESAGE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Xavier;HEBUTERNE","firstname":"Xavier","lastname":"HEBUTERNE","type":"investigator","extlink":[{"title":"SIREN","uri":"609849153","role":"organisation id"}],"email":"hebuterne.x@chu-nice.fr","affiliationName":"LILLY FRANCE","PILabo":"Eli Lilly France","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153"}]}]},"distribution_statement":{"contact":[{"name":"Xavier;HEBUTERNE","lastname":"HEBUTERNE","firstname":"Xavier","type":"contact","email":"hebuterne.x@chu-nice.fr","affiliationName":"LILLY FRANCE","contactPointLabo":"","extlink":[{"uri":"609849153","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Femmes m\u00e9nopaus\u00e9es"},{"keyword":"densit\u00e9 min\u00e9rale osseuse"},{"keyword":"ost\u00e9oporose"}],"topics":[{"topic":"Rhumatologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D012219"}]},{"topic":"Ost\u00e9oporose","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/2113001430","title":"CIM-11"}]}],"purpose":"Objectif principal : estimer le pourcentage de patients ost\u00e9oporotiques parmi les patientes m\u00e9nopaus\u00e9es r\u00e9alisant une mesure de la densit\u00e9 min\u00e9rale osseuse \u00e0 vis\u00e9e diagnostique et susceptibles de b\u00e9n\u00e9ficier des recommandations th\u00e9rapeutiques selon les recommandations fran\u00e7aises. Objectifs secondaires : facteurs associ\u00e9s \u00e0 l'ost\u00e9oporose, caract\u00e9ristiques et prise en charge des patientes","abstract":"","coll_dates":[{"start":"2007-01-01","end":"2008-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Femme m\u00e9nopaus\u00e9e, - Patiente non trait\u00e9e pour ost\u00e9oporose depuis au moins un an (THS, raloxif\u00e8ne, bisphosphonate, teriparatide, ran\u00e9late de strontium), - Patiente venant pour une densitom\u00e9trie osseuse \u00e0 vis\u00e9e diagnostique, - Patiente susceptible de b\u00e9n\u00e9ficier de recommandation th\u00e9rapeutique pour le traitement de l\u2019ost\u00e9oporose (patiente ost\u00e9op\u00e9nique ou ost\u00e9oporotique avec des facteurs de risque de fractures).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es paracliniques','Donn\u00e9es paracliniques (hors biologiques) : Imagerie']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"646"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2018","isContributorPI":false,"contributorName":"Xavier HEBUTERNE","contributorAffiliation":"LILLY FRANCE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Cahier de recueil des donn\u00e9es","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"National"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}