Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
Study NCT ID:
NCT01956461
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2013-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Teriparatide Therapy for Japanese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-18', 'studyFirstSubmitDate': '2013-09-21', 'studyFirstSubmitQcDate': '2013-10-06', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The determinants related to BMD increase and fracture prevention for teriparatide treatment', 'timeFrame': 'Up to 36 months', 'description': 'The investigators plan to analyze 500 patients who undergo teriparatide treatments 12 months. To enroll 500 participants, up to 24 months is required beside 12 months treatment periods.\n\nWe investigate several determinants related to BMD increase, such as baseline age, gender, body mass index, BMD, BTMs, history of fracture, and prior treatment. We also investigate determinants related to fracture prevention effects by teriparatide treatment, such as baseline age, gender, body mass index, BMD, BTMs, history of fracture, prior treatment, walking ability, dementia,and site of living.\n\nTo determine the response variables of BMD changes and fracture prevention effects, initially univariate analyses are performed by Spearman correlation coefficients and Mann-Whitney U test. Data are further analyzed with a multiple regression. To estimate odds ratios and 95% confidence intervals (95% CIs) of each determinants, logistic regression analyses are performed.'}], 'secondaryOutcomes': [{'measure': 'BMD and BTMs response, and fracture prevention effects of teriparatide for the patients in nursing home', 'timeFrame': 'Oct 2014', 'description': 'We plan to evaluate longitudinal BMD and BTMs changes for 24 months. BMD was evaluated every four months, ans BTMs are evaluated one months after treatment, and every four months. Fracture prevention effects are evaluated by radiography, if fracture is suspected. Statical analyses are performed using Spearman correlation coefficients, paired t-test, Mann-Whitney U test, and Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoporosis', 'BMD', 'teriparatide', 'nursing home'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.\n\nSeveral determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily.\n\nThe main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.\n\nNext, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.', 'detailedDescription': 'Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (\\< young adult mean 65%).\n\nInterventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Osteoporotic patients who admit to our hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe osteoporotic patients\n\nExclusion Criteria:\n\n* cancer, hypercalcemia, etc (i.e. patients who could not use teriparatide)'}, 'identificationModule': {'nctId': 'NCT01956461', 'briefTitle': 'Effects of Teriparatide Therapy for Japanese', 'organization': {'class': 'OTHER', 'fullName': 'Tomidahama Hospital'}, 'orgStudyIdInfo': {'id': 'IRB TH No 6'}}, 'contactsLocationsModule': {'locations': [{'zip': '510-8008', 'city': 'Yokkaichi', 'state': 'Mie-ken', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Rui Niimi, MD, PhD', 'role': 'CONTACT', 'email': 'furikakefuri@hotmail.co.jp', 'phone': '(81)-59-365-0023'}], 'facility': 'Tomidahama Hospital', 'geoPoint': {'lat': 34.96667, 'lon': 136.61667}}], 'centralContacts': [{'name': 'Rui Niimi, MD, PhD', 'role': 'CONTACT', 'email': 'furikakefuri@hotmail.co.jp', 'phone': '(81)-59-365-0023'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomidahama Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Hospital', 'investigatorFullName': 'Toshihiko Kono', 'investigatorAffiliation': 'Tomidahama Hospital'}}}}