Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT04206618
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Myokine Levels and Bone Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'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'}, {'id': 'D000069448', 'term': 'Denosumab'}], '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': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'follistatin', 'timeFrame': '0,3,12 months', 'description': 'circulating levels of myokine follistatin at baseline and their changes at 3 and 12 months with treatment'}], 'secondaryOutcomes': [{'measure': 'activin-A', 'timeFrame': '0,3,12 months', 'description': 'circulating levels of myokine activin-A at baseline and their changes at 3 and 12 months with treatment'}, {'measure': 'FSTL3', 'timeFrame': '0,3,12 months', 'description': 'circulating levels of myokine FSTL3 at baseline and their changes at 3 and 12 months with treatment'}, {'measure': 'activin-B', 'timeFrame': '0,3,12 months', 'description': 'circulating levels of activin-B at baseline and their changes at 3 and 12 months with treatment'}, {'measure': 'irisin', 'timeFrame': '0,3,12 months', 'description': 'circulating levels of myokine irisin at baseline and their changes at 3 and 12 months with treatment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis, Postmenopausal']}, 'referencesModule': {'references': [{'pmid': '23178301', 'type': 'BACKGROUND', 'citation': 'Bowser M, Herberg S, Arounleut P, Shi X, Fulzele S, Hill WD, Isales CM, Hamrick MW. Effects of the activin A-myostatin-follistatin system on aging bone and muscle progenitor cells. Exp Gerontol. 2013 Feb;48(2):290-7. doi: 10.1016/j.exger.2012.11.004. Epub 2012 Nov 21.'}, {'pmid': '21787285', 'type': 'BACKGROUND', 'citation': 'Lotinun S, Pearsall RS, Horne WC, Baron R. Activin receptor signaling: a potential therapeutic target for osteoporosis. Curr Mol Pharmacol. 2012 Jun;5(2):195-204. doi: 10.2174/1874467211205020195.'}, {'pmid': '23124716', 'type': 'BACKGROUND', 'citation': 'Anastasilakis AD, Polyzos SA, Makras P, Gkiomisi A, Savvides M, Papatheodorou A, Terpos E. Circulating activin-A is elevated in postmenopausal women with low bone mass: the three-month effect of zoledronic acid treatment. Osteoporos Int. 2013 Jul;24(7):2127-32. doi: 10.1007/s00198-012-2198-0. Epub 2012 Nov 3.'}, {'pmid': '29499419', 'type': 'BACKGROUND', 'citation': 'Lodberg A, Eijken M, van der Eerden BCJ, Okkels MW, Thomsen JS, Bruel A. A soluble activin type IIA receptor mitigates the loss of femoral neck bone strength and cancellous bone mass in a mouse model of disuse osteopenia. Bone. 2018 May;110:326-334. doi: 10.1016/j.bone.2018.02.026. Epub 2018 Feb 28.'}, {'pmid': '20080223', 'type': 'BACKGROUND', 'citation': 'Lotinun S, Pearsall RS, Davies MV, Marvell TH, Monnell TE, Ucran J, Fajardo RJ, Kumar R, Underwood KW, Seehra J, Bouxsein ML, Baron R. A soluble activin receptor Type IIA fusion protein (ACE-011) increases bone mass via a dual anabolic-antiresorptive effect in Cynomolgus monkeys. Bone. 2010 Apr;46(4):1082-8. doi: 10.1016/j.bone.2010.01.370. Epub 2010 Jan 18.'}, {'pmid': '19049340', 'type': 'BACKGROUND', 'citation': 'Ruckle J, Jacobs M, Kramer W, Pearsall AE, Kumar R, Underwood KW, Seehra J, Yang Y, Condon CH, Sherman ML. Single-dose, randomized, double-blind, placebo-controlled study of ACE-011 (ActRIIA-IgG1) in postmenopausal women. J Bone Miner Res. 2009 Apr;24(4):744-52. doi: 10.1359/jbmr.081208.'}, {'pmid': '30881954', 'type': 'BACKGROUND', 'citation': 'Fahmy-Garcia S, Farrell E, Witte-Bouma J, Robbesom-van den Berge I, Suarez M, Mumcuoglu D, Walles H, Kluijtmans SGJM, van der Eerden BCJ, van Osch GJVM, van Leeuwen JPTM, van Driel M. Follistatin Effects in Migration, Vascularization, and Osteogenesis in vitro and Bone Repair in vivo. Front Bioeng Biotechnol. 2019 Mar 1;7:38. doi: 10.3389/fbioe.2019.00038. eCollection 2019.'}, {'pmid': '30759349', 'type': 'BACKGROUND', 'citation': 'Lodberg A, van der Eerden BCJ, Boers-Sijmons B, Thomsen JS, Bruel A, van Leeuwen JPTM, Eijken M. A follistatin-based molecule increases muscle and bone mass without affecting the red blood cell count in mice. FASEB J. 2019 May;33(5):6001-6010. doi: 10.1096/fj.201801969RR. Epub 2019 Feb 13.'}, {'pmid': '38976019', 'type': 'DERIVED', 'citation': 'Anastasilakis AD, Polyzos SA, Makras P, Savvidis M, Mantzoros CS. The comparative effect of teriparatide and denosumab on activins, follistatins, and inhibins in women with postmenopausal osteoporosis. J Bone Miner Res. 2024 Sep 2;39(9):1306-1314. doi: 10.1093/jbmr/zjae106.'}, {'pmid': '37221430', 'type': 'DERIVED', 'citation': 'Anastasilakis AD, Polyzos SA, Savvidis M, Anastasilakis DA, Sarridimitriou A, Kumar A, Kalra B, Makras P, Mantzoros CS. Association of activins, follistatins and inhibins with incident hip fracture in women with postmenopausal osteoporosis: a proof of concept, case-control study. Endocrine. 2023 Sep;81(3):573-578. doi: 10.1007/s12020-023-03402-x. Epub 2023 May 23.'}, {'pmid': '36587801', 'type': 'DERIVED', 'citation': 'Anastasilakis AD, Polyzos SA, Rodopaios NE, Makras P, Kumar A, Kalra B, Mantzoros CS. Activins, follistatins and inhibins in postmenopausal osteoporosis: A proof of concept, case-control study. Metabolism. 2023 Apr;141:155397. doi: 10.1016/j.metabol.2022.155397. Epub 2022 Dec 30.'}]}, 'descriptionModule': {'briefSummary': 'Circulating levels of several myokines will be measured in serum samples obtained from women in various categories of bone density and according to the presence of fracture or not as well as before and after treatment with teriparatide and denosumab', 'detailedDescription': 'Serum samples for the measurement of several myokines will be obtained from: 1) equal groups of premenopausal women with normal BMD, postmenopausal women with normal BMD, postmenopausal women with osteopenia, and postmenopausal women with osteoporosis; 2) women with hip fracture compared with controls (women subjected to surgery due to knee osteoathritis); 3) women with osteoporosis treated with teriparatide or denosumab for 12 months'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Substudy 1: equal groups (n=25) of premenopausal women with normal BMD, postmenopausal women with normal BMD, postmenopausal women with osteopenia, and postmenopausal women with osteoporosis Substudy 2: postmenopausal women with an incident hip fracture (n=40) compared with controls (postmenopausal women with knee osteoarhtritis) Substudy 3: postmenopausal women with osteoporosis will receive treatment with either teriparatide or denosumab for 12 months', 'genderDescription': 'Postmenopausal women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubstudy 1:\n\n• adult women\n\nSubstudy 2:\n\n• postmenopausal women with an incident hip fracture\n\nSubstudy 3:\n\n• postmenopausal women with osteoporosis\n\nExclusion Criteria:\n\n* secondary osteoporosis\n* any disease that could affect muscle and/or bone metabolism\n* any medication that could affect muscle and/or bone metabolism'}, 'identificationModule': {'nctId': 'NCT04206618', 'briefTitle': 'Circulating Myokine Levels and Bone Metabolism', 'organization': {'class': 'OTHER', 'fullName': '424 General Military Hospital'}, 'officialTitle': 'The Role of Myokines in Postmenopausal Osteoporosis', 'orgStudyIdInfo': {'id': 'MYOBONE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'premenopausal normal', 'description': 'premenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage'}, {'label': 'postmenopausal normal', 'description': 'postmenopausal women with normal BMD who will be subjected to a single morning, fasting blood drainage'}, {'label': 'postmenopausal osteopenia', 'description': 'postmenopausal women with osteopenia who will be subjected to a single morning, fasting blood drainage'}, {'label': 'postmenopausal osteoporosis', 'description': 'postmenopausal women with osteoporosis who will be subjected to a single morning, fasting blood drainage'}, {'label': 'hip fracture', 'description': 'postmenopausal women at the moment of hip fracture who will be subjected to a single, fasting blood drainage right before osteosynthesis'}, {'label': 'controls (knee osteoarthitis)', 'description': 'postmenopausal women with knee osteoarthritis who will be subjected to a single, fasting blood drainage right before arthroplasty and serve as controls'}, {'label': 'teriparatide group', 'description': 'postmenopausal women with osteoporosis who will be treated with teriparatide (Forsteo) 1 injection of 20mcg subcutaneously daily for 12 months', 'interventionNames': ['Drug: Teriparatide']}, {'label': 'denosumab group', 'description': 'postmenopausal women with osteoporosis who will be treated with denosumab (Prolia) 1 injection of 60mg subcutaneously every 6 months for 12 months', 'interventionNames': ['Drug: Denosumab']}], 'interventions': [{'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['rhPTH 1-34'], 'description': '1 subcutaneous injection daily for 12 months', 'armGroupLabels': ['teriparatide group']}, {'name': 'Denosumab', 'type': 'DRUG', 'otherNames': ['RANKL inhibitor'], 'description': '1 subcutaneous injection every 6 months for 12 months', 'armGroupLabels': ['denosumab group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56429', 'city': 'Thessaloniki', 'state': 'Northern Greece', 'country': 'Greece', 'facility': '424 General Military Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Athanasios Anastasilakis, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '424 General Military Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will become available after study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '424 General Military Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Athanasios D. Anastasilakis', 'investigatorAffiliation': '424 General Military Hospital'}}}}