Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02578095
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Hip Fracture Study in Patients 65 Years or Greater
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-12', 'releaseDate': '2025-10-30'}, {'resetDate': '2025-12-23', 'releaseDate': '2025-12-05'}], 'estimatedResultsFirstSubmitDate': '2025-10-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2019-10-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2015-10-13', 'dispFirstSubmitQcDate': '2019-10-03', 'studyFirstSubmitQcDate': '2015-10-15', 'dispFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy in hip fracture patients confirmed by DXA scan.', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to investigate the safety, tolerability, and efficacy of VK5211 after 12 weeks of treatment.\n\nMales and females ≥65 years old who are ambulatory and recovering from a hip fracture will be eligible for participation 3-7 weeks post-injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation.\n\nExclusion Criteria:\n\n* Pathological fracture (e.g. fracture due to Paget's disease of bone, malignancy, etc.). Fracture due to postmenopausal osteoporosis is not considered pathological for this trial."}, 'identificationModule': {'nctId': 'NCT02578095', 'briefTitle': 'Acute Hip Fracture Study in Patients 65 Years or Greater', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viking Therapeutics, Inc.'}, 'officialTitle': 'A Phase II, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Multi-Center Study to Explore the Efficacy, Safety and Tolerability of VK5211 in Subjects With Acute Hip Fracture', 'orgStudyIdInfo': {'id': 'VK5211-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo QD', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'VK5211- 0.5mg', 'description': '0.5mgQD', 'interventionNames': ['Drug: VK5211']}, {'type': 'EXPERIMENTAL', 'label': 'VK5211- 1.0mg', 'description': '1.0mg QD', 'interventionNames': ['Drug: VK5211']}, {'type': 'EXPERIMENTAL', 'label': 'VK5211- 2.0mg', 'description': '2.0mg QD', 'interventionNames': ['Drug: VK5211']}], 'interventions': [{'name': 'VK5211', 'type': 'DRUG', 'description': 'Capsule', 'armGroupLabels': ['VK5211- 0.5mg', 'VK5211- 1.0mg', 'VK5211- 2.0mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92886', 'city': 'Yorba Linda', 'state': 'California', 'country': 'United States', 'facility': 'Duurga Clinical Service', 'geoPoint': {'lat': 33.88863, 'lon': -117.81311}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Orthopedic Research Institute', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33126', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'Infinite Clinical Research', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33136', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Shrock Orthopedic Research, LLC', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Center for Advanced Research & Education', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '49525', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Orthopaedic Association of Michigan', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Osteoporosis Clinical Research Program', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '1125', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Szent János Kórház és Észak budai Egyesített Kórházak Traumatológiai és Kézsebészeti Osztály', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'MH Egészségügyi Központ Baleseti Sebészeti Osztály', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Szent Margit Kórház, Mozgásszervi Rehabilitációs Osztály', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '9024', 'city': 'Győr', 'country': 'Hungary', 'facility': 'Petz Aladár Megyei Oktató Kórház Mozgásszervi Rehabilitációs Osztály', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Jósa András Oktató Kórház Traumatológiai és Kézsebészeti Osztály', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'SZTE ÁOK Traumatológiai Klinika', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '014461', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic de Urgenta Bucuresti ("Floreasca")', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '050098', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Universitar de Urgenţă', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '700111', 'city': 'Iași', 'country': 'Romania', 'facility': 'Spitalul Clinic Judeţean de Urgenţe, Sfȃntul Spiridon', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Institut za Ortopedsko-hirurške bolesti Banjica', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Klinički Centar Srbije', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11080', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Hospital Center "Bezanijska kosa" Department for Orthopedic Surgery and Traumatology', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '34000', 'city': 'Kragujevac', 'country': 'Serbia', 'facility': 'Clinical Center Kragujevac Department for Orthopedics and Traumatology', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'zip': '21000', 'city': 'Novi Sad', 'country': 'Serbia', 'facility': 'Clinical Centre of Vojvodina Department for Orthopedic Surgery and Traumatology', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}], 'overallOfficials': [{'name': 'Marianne Mancini', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Viking Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Viking Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-10-30', 'type': 'RELEASE'}, {'date': '2025-11-12', 'type': 'RESET'}, {'date': '2025-12-05', 'type': 'RELEASE'}, {'date': '2025-12-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Viking Therapeutics, Inc.'}}}}