Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-28 @ 12:07 AM
Study NCT ID:
NCT01472393
Status:
UNKNOWN
Last Update Posted:
2015-01-30
First Post:
2011-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creatine on Bone Mass in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-29', 'studyFirstSubmitDate': '2011-11-08', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone mineral density (BMD)', 'timeFrame': '12 and 24 months'}], 'secondaryOutcomes': [{'measure': 'bone markers', 'timeFrame': '12 and 24 months', 'description': 'will include CTX and P1NP'}, {'measure': 'history of falls', 'timeFrame': '24 months'}, {'measure': 'bone microarchitecture', 'timeFrame': '12 and 24 months'}, {'measure': 'muscle function', 'timeFrame': '12 and 24 months'}, {'measure': 'lean mass', 'timeFrame': '12 and 24 months'}, {'measure': 'laboratory parameters', 'timeFrame': '12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['creatine supplementation', 'bone mass', 'postmenopausal women', 'muscle function', 'bone markers'], 'conditions': ['Postmenopausal Women']}, 'referencesModule': {'references': [{'pmid': '31257405', 'type': 'DERIVED', 'citation': 'Sales LP, Pinto AJ, Rodrigues SF, Alvarenga JC, Goncalves N, Sampaio-Barros MM, Benatti FB, Gualano B, Rodrigues Pereira RM. Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):931-938. doi: 10.1093/gerona/glz162.'}, {'pmid': '26192975', 'type': 'DERIVED', 'citation': 'Lobo DM, Tritto AC, da Silva LR, de Oliveira PB, Benatti FB, Roschel H, Niess B, Gualano B, Pereira RM. Effects of long-term low-dose dietary creatine supplementation in older women. Exp Gerontol. 2015 Oct;70:97-104. doi: 10.1016/j.exger.2015.07.012. Epub 2015 Jul 17.'}, {'pmid': '24530883', 'type': 'DERIVED', 'citation': 'Gualano B, Macedo AR, Alves CR, Roschel H, Benatti FB, Takayama L, de Sa Pinto AL, Lima FR, Pereira RM. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. Exp Gerontol. 2014 May;53:7-15. doi: 10.1016/j.exger.2014.02.003. Epub 2014 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy postmenopausal women\n* T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD\n\nExclusion Criteria:\n\n* drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation)\n* low BMI (\\< 18.5 Kg/m2).'}, 'identificationModule': {'nctId': 'NCT01472393', 'briefTitle': 'Creatine on Bone Mass in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women', 'orgStudyIdInfo': {'id': 'USP.BONE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creatine supplementation', 'interventionNames': ['Dietary Supplement: Creatine supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: dextrose (placebo)']}], 'interventions': [{'name': 'Creatine supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The CR group will receive either 1g or 3g of Cr monohydrate (Creapure®) per day throughout the trial. The dose of creatine will be formulated in a tablet.', 'armGroupLabels': ['Creatine supplementation']}, {'name': 'dextrose (placebo)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The placebo group will be given the same dose of dextrose formulated in a tablet to be consumed under the same conditions. The two types of tablets will not be distinguishable from each other having the same appearance, taste and smell.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-903', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Melisa Madureira, PhD', 'role': 'CONTACT', 'email': 'melisamadureira@usp.br', 'phone': '5511 30617158'}, {'name': 'Bruno Gualano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': "Rosa M' Pereira, PhD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Sao Paulo - School of Medicine', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Bruno Gualano, PhD', 'role': 'CONTACT', 'email': 'gualano@usp.br', 'phone': '551130913096'}], 'overallOfficials': [{'name': 'Bruno Gualano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Rosa M Pereira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'AlzChem AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}