Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT01150032
Status:
UNKNOWN
Last Update Posted:
2017-07-07
First Post:
2010-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Quality Lyon Orleans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], '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': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Frozen plasma: for later genetic studies Frozen serum: for later studies on new potential marker of bone remodelling'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1605}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-06', 'studyFirstSubmitDate': '2010-06-23', 'studyFirstSubmitQcDate': '2010-06-23', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fragility fracture', 'timeFrame': '4 years', 'description': 'Appearance of vertebral or non-vertebral fracture during the 4 years follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Fracture', 'Bone microarchitecture'], 'conditions': ['Osteopenic Women']}, 'referencesModule': {'references': [{'pmid': '29282548', 'type': 'DERIVED', 'citation': 'Chapurlat R, Pialat JB, Merle B, Confavreux E, Duvert F, Fontanges E, Khacef F, Peres SL, Schott AM, Lespessailles E. The QUALYOR (QUalite Osseuse LYon Orleans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design. Arch Osteoporos. 2017 Dec 27;13(1):2. doi: 10.1007/s11657-017-0412-6.'}]}, 'descriptionModule': {'briefSummary': 'QUALYOR is a prospective study on the predictive value for fragility fracture of various new techniques assessing bone quality, among postmenopausal women with low bone mass.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '50 years old or older women with lowered Bone Mineral Density', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 or older women\n* post-menopausal since at least one year\n* with osteopenia (T-score between -1.0 and -2.5 (with clinical factor risk) or -3.0 (without clinical factor risk)\n\nExclusion Criteria:\n\n* corticosteroid therapy \\> 3 months, at least 7.5mg/day equivalent prednisolon (stopped since at least 1 year)\n* osteoporosis treatment antecedent\n* fragility fracture antecedent\n* on going post-menopausal hormonal treatment\n* clinical signs of hepatic, cardiac or respiratory insufficiency, diseases possibly affecting bone metabolism\n* life expectancy \\< 4 years, mental or serious illness'}, 'identificationModule': {'nctId': 'NCT01150032', 'acronym': 'QUALYOR', 'briefTitle': 'Bone Quality Lyon Orleans', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Bone Quality and Improvement of Fracture Risk Prediction', 'orgStudyIdInfo': {'id': '2009.588'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Osteopenic women', 'description': 'Women with osteopenia: Bone Mineral Density T-score between -1.0 and -2.5 (for whom with clinical factor risk) or -3.0 (for whom without clinical factor risk)', 'interventionNames': ['Other: Bone quality complementary exams']}], 'interventions': [{'name': 'Bone quality complementary exams', 'type': 'OTHER', 'description': 'realisation of following exams to evaluate fracture risk in osteopenic women:\n\n* hip and wrist Dual energy X-ray Absorptiometry (DXA)\n* wrist and shin High-Resolution peripheral Quantitative Computed-Tomography(HR-pQCT)\n* hip Quantitative Computed Tomography (QCT)\n* High Resolution Digital X-Ray of calcaneum using BMA(tm) system\n* low-dose stereoradiography using EOS(tm) system (only for a sub-group of 60 voluntary subjects)', 'armGroupLabels': ['Osteopenic women']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Orléans', 'country': 'France', 'facility': "Centre Hospitalier d'Orléans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}], 'overallOfficials': [{'name': 'Roland CHAPURLAT, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}