Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2026-01-01 @ 11:51 PM
Study NCT ID:
NCT00713258
Status:
TERMINATED
Last Update Posted:
2012-05-08
First Post:
2008-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D019386', 'term': 'Alendronate'}], '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'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@nycomed.com', 'phone': '+45 4677 1111', 'title': 'Clinical Trial Operations', 'organization': 'Nycomed'}, 'certainAgreement': {'otherDetails': "After publication of the results or 24 months after Clinical Trial Report has been finalised, whichever comes first, Nycomed acknowledge the Investigator's rights to publish results from this trial. Any such scientific paper, presentation, communication or other information concerning the trial described in this protocol must be submitted to Nycomed for review prior to submission for publication/presentation. Review comments will be given within a month from receipt of the manuscript.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'description': 'The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.', 'eventGroups': [{'id': 'EG000', 'title': 'PTH (1-84)', 'description': 'PTH (1-84) + placebo alendronate\n\n* PTH (1-84): powder and solvent for solution for injection\n* placebo alendronate: capsule', 'otherNumAtRisk': 41, 'otherNumAffected': 18, 'seriousNumAtRisk': 41, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Alendronate', 'description': 'PTH (1-84) placebo + alendronate\n\n* PTH (1-84) placebo: powder and solvent for solution for injection\n* alendronate: capsule', 'otherNumAtRisk': 34, 'otherNumAffected': 13, 'seriousNumAtRisk': 34, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal pain upper', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bursitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTH (1-84)', 'description': 'PTH (1-84) + placebo alendronate\n\n* PTH (1-84): powder and solvent for solution for injection\n* placebo alendronate: capsule'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'PTH (1-84) placebo + alendronate\n\n* PTH (1-84) placebo: powder and solvent for solution for injection\n* alendronate: capsule'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks treatment', 'description': 'The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = "no pain" and 10 = "unendurable pain").', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is "0", because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PTH (1-84)', 'description': 'PTH (1-84) + placebo alendronate\n\n* PTH (1-84): powder and solvent for solution for injection\n* placebo alendronate: capsule'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'PTH (1-84) placebo + alendronate\n\n* PTH (1-84) placebo: powder and solvent for solution for injection\n* alendronate: capsule'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks treatment', 'description': 'Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person\'s functional level is restricted by pain.\n\nODI scores from 0 = "no disability" to 100 = "maximum disability".\n\nPatient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed is "0", because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PTH (1-84)', 'description': 'PTH (1-84) + placebo alendronate\n\n* PTH (1-84): powder and solvent for solution for injection\n* placebo alendronate: capsule'}, {'id': 'FG001', 'title': 'Alendronate', 'description': 'PTH (1-84) placebo + alendronate\n\n* PTH (1-84) placebo: powder and solvent for solution for injection\n* alendronate: capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PTH (1-84)', 'description': 'PTH (1-84) + placebo alendronate\n\n* PTH (1-84): powder and solvent for solution for injection\n* placebo alendronate: capsule'}, {'id': 'BG001', 'title': 'Alendronate', 'description': 'PTH (1-84) placebo + alendronate\n\n* PTH (1-84) placebo: powder and solvent for solution for injection\n* alendronate: capsule'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.7', 'spread': '9.14', 'groupId': 'BG000'}, {'value': '69.8', 'spread': '7.84', 'groupId': 'BG001'}, {'value': '70.3', 'spread': '8.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Vertebral Fracture at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '3.44', 'spread': '2.49', 'groupId': 'BG000'}, {'value': '2.94', 'spread': '1.97', 'groupId': 'BG001'}, {'value': '3.21', 'spread': '2.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The baseline measure is shown as average number per patient.', 'unitOfMeasure': 'vertebral fractures per patient', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Family history of osteoporosis', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'A family history of osteoporosis was reported by 22 subjects, which differs from the overall number of baseline participants.', 'unitOfMeasure': 'patients'}, {'title': 'Age at onset of menopause', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '3.68', 'groupId': 'BG000'}, {'value': '48.6', 'spread': '5.25', 'groupId': 'BG001'}, {'value': '48.5', 'spread': '4.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean NRS score', 'classes': [{'categories': [{'measurements': [{'value': '6.60', 'spread': '1.45', 'groupId': 'BG000'}, {'value': '6.36', 'spread': '1.70', 'groupId': 'BG001'}, {'value': '6.49', 'spread': '1.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'NRS = 11-point numerical rating scale to assess the pain. The NRS score ranges from 0 to 10, with lower scores meaning less pain.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'whyStopped': 'Slow enrolment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2008-07-02', 'resultsFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2008-07-10', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-02', 'studyFirstPostDateStruct': {'date': '2008-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.', 'timeFrame': 'Baseline and 24 weeks treatment', 'description': 'The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = "no pain" and 10 = "unendurable pain").'}], 'secondaryOutcomes': [{'measure': 'Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment', 'timeFrame': 'Baseline and 24 weeks treatment', 'description': 'Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person\'s functional level is restricted by pain.\n\nODI scores from 0 = "no disability" to 100 = "maximum disability".\n\nPatient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postmenopausal women', 'Back pain', 'Osteoporosis related fracture'], 'conditions': ['Back Pain']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).\n\nSecondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.\n\nExclusion Criteria:\n\n* Previous/current treatment and medical history.'}, 'identificationModule': {'nctId': 'NCT00713258', 'briefTitle': 'The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nycomed'}, 'officialTitle': 'A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 µg PTH(1-84) Daily or 70 mg Alendronate Weekly', 'orgStudyIdInfo': {'id': 'FP-005-IM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PTH (1-84)', 'description': 'PTH (1-84) + placebo alendronate', 'interventionNames': ['Drug: Parathyroid hormone (PTH) (1-84)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alendronate', 'description': 'PTH (1-84) placebo + alendronate', 'interventionNames': ['Drug: Alendronate']}], 'interventions': [{'name': 'Parathyroid hormone (PTH) (1-84)', 'type': 'DRUG', 'description': '100 µg PTH(1-84) daily', 'armGroupLabels': ['PTH (1-84)']}, {'name': 'Alendronate', 'type': 'DRUG', 'description': '70 mg alendronate weekly', 'armGroupLabels': ['Alendronate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Nycomed', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nycomed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}