Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 12:23 PM
Study NCT ID:
NCT05909228
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2023-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Markers in Pediatric IF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090124', 'term': 'Intestinal Failure'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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_WITHOUT_DNA', 'description': 'Bone markers: osteocalcin, bone-specific alkaline phosphatase and c-telopeptide'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone turnover markers - Osteocalcin', 'timeFrame': 'Baseline', 'description': 'To measure serum osteocalcin levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.'}, {'measure': 'Bone turnover markers - C-telopeptide', 'timeFrame': 'Baseline', 'description': 'To measure serum C-telopeptide levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.'}, {'measure': 'Bone turnover markers - Bone-specific alkaline phosphatase', 'timeFrame': 'Baseline', 'description': 'To measure serum bone-specific alkaline phosphatase levels in children with intestinal failure on long-term parenteral nutrition and compare them with age- and sex-matched healthy children who never received parenteral nutrition.'}], 'secondaryOutcomes': [{'measure': 'Bone health', 'timeFrame': 'DXA scan results will be collected when performed within 6 months of the blood draw for the bone markers.', 'description': 'Association of serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase with bone mineral density Z-scores for lumber spine and total body less head obtained from DXA scans performed as standard clinical care.'}, {'measure': 'Intestinal failure and parenteral nutrition related factors', 'timeFrame': 'Baseline', 'description': 'Association of intestinal failure and parenteral nutrition related factors such as duration of parenteral nutrition (y) with serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase levels.'}, {'measure': 'Intestinal failure and parenteral nutrition related factors', 'timeFrame': 'Intestinal failure and parenteral nutrition related factors', 'description': 'Association of intestinal failure and parenteral nutrition related factors such as parenteral nutrition dependency index (%) with serum osteocalcin, C-telopeptide and bone-specific alkaline phosphatase levels.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intestinal Failure', 'Osteoporosis', 'Metabolic Bone Disease']}, 'descriptionModule': {'briefSummary': 'Poor bone health is a well-recognized but poorly understood complication in children with intestinal failure (IF) who are dependent on parenteral nutrition (PN). Previously, we showed that children with IF have decreased bone turnover markers. It is currently unknown if optimization of parenteral nutrition is related to improved bone turnover markers. Serum concentrations of bone markers (osteocalcin, bone-specific alkaline phosphatase and c-telopeptide) will be measured in 30 IF patients treated at a multidisciplinary intestinal rehabilitation and home PN program at the Hospital for Sick Children and compared to bone markers in 30 age- and sex-matched healthy controls.', 'detailedDescription': 'It is currently unknown if optimization of PN mixtures leads to a measurable change in bone turnover markers. Our hypothesis is that bone turnover markers of children with IF whose PN has been optimized will not differ from those of healthy control subjects, with a positive effect on bone mineral density.\n\nOur aims are:\n\n* To measure bone turnover markers in children with IF on long-term PN and compare them with age- and sex-matched healthy children who never received PN\n* To evaluate if changes in bone turnover markers are related to changes in bone mineral density measured by Dual energy X-ray absorptiometry (DXA)\n* To identify IF- and PN-related factors associated with bone health\n\nTo be able to answer these aims, bone markers in children with IF will be compared to bone markers in healthy controls, age- and sex-matched.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with intestinal failure on parenteral nutrition and healthy controls without parenteral nutrition.', 'eligibilityCriteria': 'Inclusion criteria are as follows:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria at time of inclusion:\n\n1. Consent provided\n2. Age \\< 18 years\n3. Suffering from IF needing PN providing at least 25% of calories for ≥6 weeks\n4. Medically stable with no acute changes in condition requiring hospitalization, or other intervention at home (for at least 3 months).\n\nFor healthy controls the inclusion criteria are as follows:\n\n1. Consent provided\n2. Age \\< 18 years.\n\nA patient who meets any of the following criteria will be excluded from participation in this study:\n\n1. On PN for \\< 6 weeks\n2. Suffering from an acute clinical event, for example gastroenteritis, colds and flu\n3. Suffering from sepsis on antibiotics\n4. On medication known to affect bone metabolism, for example steroids\n5. Having a history of fracture within the last 12 months.\n\nFor healthy controls, the exclusion criteria are as follows:\n\n1. Any condition known to affect bone health (chronic disease, bone disease, history of malignancy, radiotherapy, steroid use, mental or physical disability)\n2. A positive history of fractures within the past 2 years\n3. Poor growth (weight- and height-for-age below - 2 or above + 2 standard deviation score using the WHO growth charts).'}, 'identificationModule': {'nctId': 'NCT05909228', 'briefTitle': 'Bone Markers in Pediatric IF', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Bone Turnover Markers in Children With Intestinal Failure After Optimization of Parenteral Nutrition', 'orgStudyIdInfo': {'id': '1000080417'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with intestinal failure', 'description': 'Children with intestinal failure on parenteral nutrition'}, {'label': 'Healthy controls', 'description': 'Healthy controls without parenteral nutrition'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Glenda Courtney-Martin, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Glenda Courtney-Martin', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}