Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT01587456
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2012-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, Plasma and DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2012-04-27', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoporosis'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The investigators planned to study relationship between osteoporosis and arterial rigidity within fractured patients cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women and men \\> 60 years of age with medical history of low energy fracture andradiologic osteoporosis with DXA Tscore at -2,5 DS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women and men \\> 60 years of age\n* medical history of low energy fracture\n* DXA Tscore -2,5 DS\n* FREE AND INFORMED CONSENT SIGNED\n\nExclusion Criteria:\n\n* women and men \\< 60 years of age\n* Corticoids treatment\n* Breast cancer or prostat cancer medical history\n* High energy fracture (traumatic fracture)\n* No social security affiliation\n* Incapacity to informed consent signed.'}, 'identificationModule': {'nctId': 'NCT01587456', 'acronym': 'ARTEOS2', 'briefTitle': 'Arteos II Study: Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Relationship Between Osteoporosis and Arterial Rigidity Within Fractured Patients Cohort.', 'orgStudyIdInfo': {'id': '2011-A00453-38'}}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Georges WERYHA, Professor', 'role': 'CONTACT', 'email': 'g.weryha@chu-nancy.fr', 'phone': '33 3 83 15 35 05'}, {'name': 'Anna KEARNEY-SCHWARTZ, Doctor', 'role': 'CONTACT', 'email': 'a.kearney-schwartz@chu-nancy.fr', 'phone': '33 3 83 15 33 22'}, {'name': 'Georges WERYHA, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anna KEARNEY SCHWARTZ, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anna ANGELOUSI, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Athanase BENETOS, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shiva KHORSAND, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lelia GROZA, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eva FEIGERLOVA, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paolo SALVI, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Brabois Endocrinology', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Georges WERYHA, MD, PHD', 'role': 'CONTACT', 'email': 'g.weryha@chu-nancy.fr', 'phone': '33 3 83 15 35 05'}, {'name': 'Anna KEARNEY SCHWARTZ, MD', 'role': 'CONTACT', 'email': 'a.kearney-schwartz@chu-nancy.fr', 'phone': '+33 3 83 15 33 22'}], 'overallOfficials': [{'name': 'Georges WERYHA, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Brabois Endocrinology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}