Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:11 AM
Study NCT ID:
NCT06016634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2023-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D007873', 'term': 'Legg-Calve-Perthes Disease'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005271', 'term': 'Femur Head Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective cohort of 30 adults with sickle cell disease and hip osteonecrosis'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-08-22', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment and retention rates', 'timeFrame': 'up to 28 weeks', 'description': 'Proportion of eligible patients who get recruited to the study; number of enrolled patients who complete 6-month study'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events as assessed by participant report', 'timeFrame': 'up to 28 weeks', 'description': 'Collect all adverse events reported by patients and determine if related to study drug'}, {'measure': 'Pain assessed by the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact questionnaire', 'timeFrame': 'up to 28 weeks', 'description': 'The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact questionnaire is a patient-reported outcome measure of pain level in the past 7 days. The ASCQ-Me pain scale ranges from 0-100, with a standardized mean of 50 and a standard deviation of 10, where lower scores signify worse disease impact.'}], 'secondaryOutcomes': [{'measure': 'Serum CTX-1', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Measurement of C-terminal telopeptide of type I collagen (CTX) in serum as a biomarker for osteoclast activity (bone resorption)'}, {'measure': 'Serum P1NP', 'timeFrame': 'baseline, 3 months, 6 months', 'description': 'Measurement of Procollagen type I N-terminal propeptide (P1NP) in serum as a biomarker for osteoblast activity (bone formation)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sickle cell disease', 'sickle cell anemia', 'osteonecrosis of the femoral head', 'hip osteonecrosis', 'ischemic necrosis of the femur', 'avascular necrosis of the femur'], 'conditions': ['Sickle Cell Disease', 'Sickle Cell Anemia', 'Osteonecrosis', 'Ischemic Necrosis', 'Avascular Necrosis']}, 'descriptionModule': {'briefSummary': 'A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis', 'detailedDescription': "The investigators hypothesize that adults with sickle cell disease (SCD) and osteonecrosis of the femoral (hip) and/or humeral (shoulder) heads will tolerate oral alendronate 70 mg administered once a week x 24 weeks (6 months). In addition to collecting safety and tolerability data on alendronate in study participants, the investigators will also measure the preliminary efficacy of alendronate using changes in the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact scores from baseline to 3-months and 6-months after alendronate initiation. Serum and urine specimen will also be collected to assess changes in bone biomarkers at baseline, 3-months, and 6-months.\n\nThe investigators plan to recruit 24 adults with SCD from the University of California Davis Medical Center to this single-arm, open label, interventional study. The investigators anticipate enrolling 1-2 participants per month between Sep 2024- Dec 2025.\n\nThe study endpoints are summarized below:\n\n* To determine the recruitment and retention rates of adults with SCD and osteonecrosis enrolled in this prospective, single-arm, open label alendronate interventional study\n* To measure the safety, tolerability, and preliminary efficacy of oral alendronate in adults with SCD-related osteonecrosis over a 6-month treatment duration\n* To measure changes in bone biomarkers in the serum and urine of study participants not receiving chronic red blood cell transfusions at 3 time points: baseline, 3-months, and 6-months after initiation of alendronate\n\nThe investigators' goal is to complete primary data analysis by May 2026."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years with SCD (any genotype, confirmed by hemoglobin electrophoresis or high performance liquid chromatography)\n* Ability to provide written informed consent\n* Ability to lay on a dual-energy X-ray absorptiometry (DXA) scanner\n* Negative urine pregnancy test for anyone of childbearing potential at study entry\n\nExclusion Criteria:\n\n* Pregnant women\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Hospitalizations (for any cause) within 2 weeks of study entry'}, 'identificationModule': {'nctId': 'NCT06016634', 'briefTitle': 'Alendronate for Osteonecrosis in Adults With Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease', 'orgStudyIdInfo': {'id': '1693339'}, 'secondaryIdInfos': [{'id': '5K23HL148310', 'link': 'https://reporter.nih.gov/quickSearch/5K23HL148310', 'type': 'NIH'}, {'id': '2020095', 'type': 'OTHER_GRANT', 'domain': 'Doris Duke Charitable Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alendronate group', 'description': 'Single-arm prospective cohort of 30 adult with SCD', 'interventionNames': ['Drug: Alendronate Sodium']}], 'interventions': [{'name': 'Alendronate Sodium', 'type': 'DRUG', 'otherNames': ['alendronate tablet', 'oral alendronate', 'Fosamax', 'Binosto'], 'description': 'Administer oral alendronate 70 mg once a week x 24 weeks to all study participants', 'armGroupLabels': ['Alendronate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Leyla Y Teos, PhD', 'role': 'CONTACT', 'email': 'lyteos@ucdavis.edu', 'phone': '916-460-2749'}, {'name': 'Oyebimpe O Adesina, MD, MS', 'role': 'CONTACT', 'email': 'adesina@ucdavis.edu', 'phone': '(916) 703-5166'}, {'name': 'Oyebimpe O Adesina, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Leyla Y Teos, PhD', 'role': 'CONTACT', 'email': 'lyteos@ucdavis.edu', 'phone': '(916) 460-2749'}], 'overallOfficials': [{'name': 'Oyebimpe O Adesina, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Davis School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Doris Duke Charitable Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}