Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-31 @ 5:36 AM
Study NCT ID:
NCT06898060
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-27
First Post:
2025-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 282}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week', 'timeFrame': 'Baseline to 52 Week', 'description': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week', 'timeFrame': 'Baseline to 26 Week', 'description': 'Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week'}, {'measure': 'Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week', 'timeFrame': 'Baseline to 26/52 Week', 'description': 'Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week'}, {'measure': 'Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week', 'timeFrame': 'Baseline to 26/52 Week', 'description': 'Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postmenopausal Women With Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women who can walk freely (≥50 and ≤85 years);\n* The patient has a body mass index(BMI) of 17.0 kg/m2 to 30 kg/m2；\n* The patient has a bone mineral density T-score≤-2.5 and \\> -5.0 at the lumbar spine (L1-L4) or femoral neck or total hip by dual energy x-ray absorptiometry (DXA)；\n* The patient has at least one of the following high risk factors of fracture: 1) history of previous fragility fractures; 2) family history of hip fragility fracture; 3) age≥70 years; 4) BMI≤19.0 kg/m2；5) Currently smoking.\n* The patient with at least 2 consecutive vertebrae(L1 to L4) and at least 1 hip can be evaluated for BMD.\n\nExclusion Criteria:\n\n* In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism；\n* History of osteosarcoma；\n* History of orthostatic hypotension；\n* Currently suffering from active urinary calculus；\n* Received anti-osteoporosis treatment that does not meet protocol requirements；\n* Received medication that affects bone metabolism within 4 weeks prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period.'}, 'identificationModule': {'nctId': 'NCT06898060', 'briefTitle': 'To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Open-label, Parallel Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture', 'orgStudyIdInfo': {'id': 'QLG2128-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLG2128', 'interventionNames': ['Drug: QLG2128']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Teriparatide Injection', 'interventionNames': ['Drug: Teriparatide Injection']}], 'interventions': [{'name': 'QLG2128', 'type': 'DRUG', 'description': 'Recommended dosage is 80 μg subcutaneously once daily，52week', 'armGroupLabels': ['QLG2128']}, {'name': 'Teriparatide Injection', 'type': 'DRUG', 'description': 'Recommended dosage is 20μg subcutaneously once daily，52week', 'armGroupLabels': ['Teriparatide Injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'zhenlin Zhang, Doctor', 'role': 'CONTACT', 'email': 'zzl2002@medmail.com', 'phone': '13621673716'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}