Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT07028320
Status:
COMPLETED
Last Update Posted:
2025-06-25
First Post:
2025-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019379', 'term': 'Teriparatide'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D019386', 'term': 'Alendronate'}], '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'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 493}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks', 'timeFrame': 'Baseline to 48 Weeks', 'description': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 48 Weeks'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine from Baseline to 24 Weeks', 'timeFrame': 'Baseline to 24 Weeks', 'description': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 24 Weeks'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) of Total Hip from Baseline to 24/48 Weeks', 'timeFrame': 'Baseline to 24/48 Weeks', 'description': 'Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to 24/48 Weeks'}, {'measure': 'Percent Change in S-CTX and P1NP From Baseline to12/ 24/48 Weeks', 'timeFrame': 'Baseline to 12/24/48 Weeks', 'description': 'Percent Change in S-CTX and P1NP From Baseline to 12/24/48 Weeks'}, {'measure': 'Proportion of Subjects with New Fragility Fractures from Baseline to 24/48 Week', 'timeFrame': 'Baseline to 24/48 Weeks', 'description': 'Proportion of Subjects With New Fragility Fractures from Baseline to 24/48 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postmenopausal Women With Osteoporosis; Teriparatide'], 'conditions': ['Postmenopausal Women With Osteoporosis']}, 'descriptionModule': {'briefSummary': 'To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women with Osteoporosis at High Fracture Risk', 'detailedDescription': 'The trial consists of a screening period (4 weeks), an open-label treatment period (up to 48 weeks), and a follow-up period (1 weeks), totaling approximately 53 weeks. Subjects who withdraw early will be asked to complete an end of treatment visit, and a safety follow-up visit 2 weeks after the end of treatment visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Postmenopausal women with the ability to live independently (≥45 and ≤80 years);\n2. The patient has a body mass index(BMI) of 18.0 kg/m2 to 30 kg/m2； The patient has one of the following diagnostic criteria for osteoporosis and subject has at least 2 consecutive vertebrae region (L1 to L4) that are evaluable by dual-energy x-ray absorptiometry (DXA)，a) History of hip/vertebra fragility fracture and bone mineral density (BMD) T-score ≤-1; b）the axial bone (lumbar , femoral neck or total hip) mineral density (BMD) T-score ≤-2.50;c) Bone mineral density (BMD) T-score ≥-2.5 and ≤-1 with proximal humerus, pelvis, or distal forearm end fragility fracture\n\nExclusion Criteria:\n\n1. In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;\n2. Patients with other diseases affecting calcium or bone metabolism;\n3. Received anti-osteoporosis treatment that does not meet protocol requirements;\n4. Received medication that affects bone metabolism prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period;\n5. Patients requiring long-term or continuous use of digoxin and other digitalis drugs during the trial;\n6. Patients with other severe underlying diseases； Patients with abnormal indicators that does not meet protocol requirements during the screening periodlaboratory tests'}, 'identificationModule': {'nctId': 'NCT07028320', 'briefTitle': 'To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Salubris Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Open-label, Parallel Controlled, Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SAL056 (Teriparatide for Injection ) in the Treatment of Postmenopausal Women With Osteoporosis at High Fracture Risk', 'orgStudyIdInfo': {'id': 'SAL056A301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: SAL056 (56.5μg)', 'description': 'Administered by subcutaneous injection once a week during treatment phase', 'interventionNames': ['Drug: SAL056 (56.5μg)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Drug: Alendronate', 'description': '70 mg tablet taken once a week during treatment phase', 'interventionNames': ['Drug: Alendronate']}], 'interventions': [{'name': 'SAL056 (56.5μg)', 'type': 'DRUG', 'otherNames': ['Teriparatide for Injection'], 'description': 'Administered by subcutaneous injection once a week during treatment phase', 'armGroupLabels': ['Drug: SAL056 (56.5μg)']}, {'name': 'Alendronate', 'type': 'DRUG', 'description': '70 mg tablet taken once a week during treatment phase', 'armGroupLabels': ['Drug: Alendronate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Sixth People's Hosptital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zheng Lin Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 6th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Salubris Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}