Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-05 @ 6:58 PM
Study NCT ID:
NCT01604057
Status:
UNKNOWN
Last Update Posted:
2012-05-23
First Post:
2012-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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': 'D059085', 'term': 'Nasal Sprays'}, {'id': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'id': 'D000336', 'term': 'Aerosols'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-21', 'studyFirstSubmitDate': '2012-05-18', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum P1NP from baseline to end of treatment.', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in serum calcium and incidence of hypercalcemia (pre-dose and post-dose)', 'timeFrame': 'baseline and 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Osteopenia']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to evaluate the effect treatment has on serum P1NP levels, a biomarker of bone formation in postmenopausal women with low bone mass.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal Females Age ≥ 45 years.\n* Weight \\> 45 kg and \\< 90 kg\n* Normal nasal examination at baseline.\n* Low bone mass at lumbar spine, total hip or femoral neck (BMD T-score of ≤ - 1.5 or lower) or a recent (within 5 years of baseline) history of fragility fracture (excluding fractures of hands, feet, face and/or skull) and a T-score of -1.0 or lower at lumbar spine, total hip or femoral neck\n\nExclusion Criteria:\n\n* Serious Medical Condition\n* History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, any secondary causes of osteoporosis, hypoparathyroidism, or hyperparathyroidism\n* Have a history of cancer within the past 5 years, except for basal cell carcinoma\n* Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney stones or pre-existing hypercalciuria;\n* Have used any of the mostly commonly prescribed osteoporosis medications within 3 months of starting the investigational product, or for more than 1 month at any time within 6 months prior to starting investigational product"}, 'identificationModule': {'nctId': 'NCT01604057', 'briefTitle': 'Study to Evaluate Effect of Intranasal Teriparatide on Serum P1NP, a Biomarker of Bone Formation, in Postmenopausal Women With Low Bone Mass', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azelon Pharmaceuticals'}, 'officialTitle': 'A Parallel Group Study to Evaluate the Effect of Six Weeks of Treatment With Nasal Spray (NS) ZT-034, Compared to Subcutaneous (SC) Forteo and Placebo, on Bone Formation, as Assessed by Stimulation of Serum P1NP Levels in Postmenopausal Women With Low Bone Mass', 'orgStudyIdInfo': {'id': 'ZT-3201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose Nasal Spray', 'interventionNames': ['Drug: ZT-034 Low Dose Nasal Spray']}, {'type': 'EXPERIMENTAL', 'label': 'Mid Dose Nasal Spray', 'interventionNames': ['Drug: ZT-034 Mid Dose Nasal Spray']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Nasal Spray', 'interventionNames': ['Drug: ZT-034 High Dose Nasal Spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Forteo', 'description': '20ug subcutaneous injection daily', 'interventionNames': ['Drug: Teriparatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Nasal Spray', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ZT-034 Low Dose Nasal Spray', 'type': 'DRUG', 'description': 'Nasal Spray', 'armGroupLabels': ['Low Dose Nasal Spray']}, {'name': 'ZT-034 Mid Dose Nasal Spray', 'type': 'DRUG', 'description': 'Nasal Spray', 'armGroupLabels': ['Mid Dose Nasal Spray']}, {'name': 'ZT-034 High Dose Nasal Spray', 'type': 'DRUG', 'description': 'Nasal Spray', 'armGroupLabels': ['High Dose Nasal Spray']}, {'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['Forteo'], 'description': '20 mcg subcutaneous daily', 'armGroupLabels': ['Forteo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Nasal Spray', 'armGroupLabels': ['Placebo Nasal Spray']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Brian MacDonald', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Azelon Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azelon Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}