Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00515593
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2007-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2007-08-13', 'studyFirstSubmitQcDate': '2007-08-13', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteoporosis', 'postmenopausal women', 'Severe postmenopausal osteoporosis'], 'conditions': ['Postmenopause', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '21155613', 'type': 'DERIVED', 'citation': 'Moricke R, Rettig K, Bethke TD. Use of recombinant human parathyroid hormone(1-84) in patients with postmenopausal osteoporosis: a prospective, open-label, single-arm, multicentre, observational cohort study of the effects of treatment on quality of life and pain--the PROPOSE study. Clin Drug Investig. 2011;31(2):87-99. doi: 10.2165/11538880-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of the study are\n\n* to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire)\n* pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score)\n* to describe bone mineral density at the beginning of the Preotact® treatment and at the end of the observational period (T-Score)\n* to describe incidence of bone fractures caused by osteoporosis as well as of other pathological findings of the skeleton after the beginning of the Preotact® treatment\n* to describe serum level of calcium and the bone resorption marker desoxypyridinoline (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the beginning of the Preotact® treatment and at the end of the observational period (only in subgroup of patients, where the physician sees a need to measure these parameters)\n* to document all adverse drug reactions after the beginning of the Preotact® treatment\n* the analysis of subgroups with different risk for bone fractures caused by osteoporosis at the beginning of the Preotact® treatment\n* to assess the manageability and functioning of the Pen system for injection of Preotact® (self administered questionnaire)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe postmenopausal osteoporosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion requires that Preotact® is prescribed in accordance with the SPC and that the stated contraindications are strictly considered.\n* Caution should be taken by the treating Physician concerning any precautions, warnings and potential drug interactions stated in the SPC.\n* No further inclusion or exclusion parameters are defined. The decision for the individual application of Preotact® will be strictly made by the physicians.'}, 'identificationModule': {'nctId': 'NCT00515593', 'briefTitle': 'PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nycomed'}, 'officialTitle': 'Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis', 'orgStudyIdInfo': {'id': 'FP-004-DE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Parathyroid hormone (PTH) (Preotact)', 'type': 'DRUG', 'description': 'Patients with severe postmenopausal osteoporosis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cities in Germany', 'country': 'Germany', 'facility': 'Nycomed Deutschland GmbH'}], 'overallOfficials': [{'name': 'Nycomed Clinical Trial Operations', 'role': 'STUDY_CHAIR', 'affiliation': 'Headquaters'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nycomed', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Nycomed', 'oldOrganization': 'Nycomed'}}}}