Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-03-06 @ 9:38 AM
Study NCT ID:
NCT01788267
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2013-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Microarchitecture in Young Cystic Fibrosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Tibial Bone Mass Density measured by High-Resolution peripheral Quantitative Computed Tomography', 'timeFrame': 'at the inclusion visit J0'}], 'secondaryOutcomes': [{'measure': 'total radial bone mass density', 'timeFrame': 'at the inclusion visit J0'}, {'measure': 'Trabecular bone micro-architecture at tibia and radial sites', 'timeFrame': 'at the inclusion visit J0'}, {'measure': 'Biological markers : 1) bone markers : parathyroid hormone (PTH), Calcifediol (25(OH)D3), osteocalcin, Endocrinal markers : IGF-1 (insulin like growth factor ), IGFBP-3, leptin, adiponectin, visfatin, resistin', 'timeFrame': 'at the inclusion visit J0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'High-Resolution peripheral Quantitative Computed Tomography', 'Bone Mass Density'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '28795206', 'type': 'RESULT', 'citation': 'Braun C, Bacchetta J, Braillon P, Chapurlat R, Drai J, Reix P. Children and adolescents with cystic fibrosis display moderate bone microarchitecture abnormalities: data from high-resolution peripheral quantitative computed tomography. Osteoporos Int. 2017 Nov;28(11):3179-3188. doi: 10.1007/s00198-017-4179-9. Epub 2017 Aug 9.'}]}, 'descriptionModule': {'briefSummary': "Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD) potentially leading to pathological fractures at adult age. Recent data from our center and others have suggested that low BMD could be observed very early in life. However, quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength).\n\nHigh-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology with very high spatial resolution. Images obtained with this technic are considered as virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces exploration in a three-dimensional manner, and therefore provides informations on bone microarchitecture as well as bone density.\n\nThe aim of this study is to evaluate bone microarchitecture of paediatric patients matched to sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore potential correlations HR-pQCT parameters."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cystic Fibrosis patient of both sex\n* Pubertal patient\n* Age ≥10 years and ≤18 years on the date of informed consent\n* FEV1(forced expiratory volume at one second ) ≥ 60% of predicted normal for age, gender and height\n* Patient on a clinical stable period\n\nExclusion Criteria:\n\n* Unable to maintain arm and/or leg immobile for 3 minutes\n* History of solid organ transplantation\n* Participation in the same time to a clinical trial\n* Acute pulmonary exacerbation at the time of evaluation'}, 'identificationModule': {'nctId': 'NCT01788267', 'briefTitle': 'Bone Microarchitecture in Young Cystic Fibrosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of the Bone Microarchitecture in a Young Cystic Fibrosis Patients Using High-Resolution Peripheral Quantitative Computed Tomography', 'orgStudyIdInfo': {'id': '2011.678'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'description': 'Volunteers realize a HR-pQCT scanner', 'interventionNames': ['Other: scan examination HR-pQCT']}, {'type': 'EXPERIMENTAL', 'label': 'Cystic Fibrosis patient', 'description': 'Patients realize a HR-pQCT scanner', 'interventionNames': ['Other: scan examination HR-pQCT']}], 'interventions': [{'name': 'scan examination HR-pQCT', 'type': 'OTHER', 'armGroupLabels': ['Cystic Fibrosis patient', 'Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Femme-Mère-Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}