Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-02 @ 6:44 PM
Study NCT ID:
NCT00535860
Status:
COMPLETED
Last Update Posted:
2009-07-10
First Post:
2007-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'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': {'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': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-09', 'studyFirstSubmitDate': '2007-09-25', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to endpoint 96 days in procollagen 1 N-terminal propeptide (P1NP)', 'timeFrame': 'Baseline, 96 days'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in C-terminal telopeptide of type I collagen (CTX-1.)', 'timeFrame': 'Baseline, 96 days'}, {'measure': 'hPTH (1-34) Pharmacokinetic AUC of ViaDerm-hPTH (1-34) and teriparatide SC.', 'timeFrame': 'Baseline, 96 days'}, {'measure': 'Ratio of hPTH (1-34) AUC of transdermal treatment and subcutaneous injection', 'timeFrame': 'Baseline, 96 days'}, {'measure': 'Ratio of hPTH (1-34) Cmax of transdermal treatment and subcutaneous injection', 'timeFrame': 'Baseline, 96 days'}, {'measure': 'hPTH (1-34) Pharmacokinetic Cmax of ViaDerm-hPTH (1-34) and teriparatide SC.', 'timeFrame': 'Baseline, 96 Days'}, {'measure': 'Percentage of patients with serum total calcium above the upper limit of normal range', 'timeFrame': 'Over 96 days'}, {'measure': 'Percentage of patients with serum total calcium more than 1 mg/dl above the upper limit of normal range', 'timeFrame': 'Over 96 days'}, {'measure': 'Number of participants with hPTH (1-34) specific antibody immune response', 'timeFrame': 'Baseline, 96 days'}, {'measure': 'Draize score for erythema and edema', 'timeFrame': 'Over 96 Days'}, {'measure': 'Visual Analog Scale (VAS) pain assessment', 'timeFrame': 'Over 96 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Transdermal', 'hPTH(1-34)'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the clinical efficacy, safety, and tolerability of ViaDerm-shPTH \\[1-34\\] transdermal delivery in comparison to subcutaneous injection of rhPTH\\[1-34\\] following 3-month treatment in postmenopausal women with Osteoporosis'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Main Inclusive Criteria:\n\n* Post-menopausal women aged between 55 to 85 years (inclusive)\n* Posterior-Anterior lumbar vertebral and/or femoral neck BMD T-score by DXA ≤-2.5 SD.\n* Have normal serum PTH, thyroid stimulating hormone (TSH) (only for patients treated with thyroid hormone), and prolactin values.\n\nMain Exclusive Criteria:\n\n* Subjects who have a clinical significant or unstable medical or surgical condition that may preclude safe and complete study participation\n* Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease\n* Prior osteoporosis treatment with fluoride or strontium at any time; or any IV treatment with bisphosphonates in the past or oral bisphosphonate for more than 1 month in the past 24 months prior to randomization.\n* Any condition or disease that may interfere with the ability to have, or to evaluate a DXA scan"}, 'identificationModule': {'nctId': 'NCT00535860', 'briefTitle': 'Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'TransPharma Medical'}, 'officialTitle': 'A Multicenter, Randomized, Parallel Study to Assess the Clinical Efficacy, Safety, and Tolerability of ViaDerm-hPTH (1-34) in Comparison to Subcutaneous Injection of Forteo in Postmenopausal Women With Osteoporosis', 'orgStudyIdInfo': {'id': 'CS 82-000-04'}, 'secondaryIdInfos': [{'id': 'I2Y-MC-GHFE'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 mcg', 'description': 'ViaDerm transdermal delivery', 'interventionNames': ['Drug: Teriparatide']}, {'type': 'EXPERIMENTAL', 'label': '80 mcg', 'description': 'Add Via-Derm transdermal delivery', 'interventionNames': ['Drug: Teriparatide']}, {'type': 'ACTIVE_COMPARATOR', 'label': '20 mcg', 'description': 'Subcutaneous injection', 'interventionNames': ['Drug: Teriparatide']}], 'interventions': [{'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['Forteo', 'Forsteo', 'LY333334'], 'description': 'Daily for 96 days', 'armGroupLabels': ['20 mcg', '50 mcg', '80 mcg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Osteocentrum FN', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Osteocentrum 3 .Interni Klinika 1. LFUK a VFN', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'Drug Research Center', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University Department of Orthopedic', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Kenezy Gyula Hospital Department of Rheumatology', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'city': 'Hévíz', 'country': 'Hungary', 'facility': 'Szent Andras Hospital-Heviz', 'geoPoint': {'lat': 46.79031, 'lon': 17.18408}}, {'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Szent Ferenc Hospital Department of Rheumatology', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yafe Medical Center - Endocrinology dep', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Center Osteoporosis Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Efrat Kochba, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TransPharma-Medical Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TransPharma Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Efrat Kochba', 'oldOrganization': 'TransPharma Medical Ltd.'}}}}