Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-01 @ 1:19 AM
Study NCT ID:
NCT01690000
Status:
COMPLETED
Last Update Posted:
2016-05-06
First Post:
2012-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Osteopenia With Melatonin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'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': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anne_kristine_am@hotmail.com', 'phone': '4578467681', 'title': 'Anne Kristine Amstrup', 'organization': 'Aarhus University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months (entire study period)', 'eventGroups': [{'id': 'EG000', 'title': 'Melatonin1+3', 'description': 'Melatonin: 1 or 3 mg of melatonin PO each night for 12 months', 'otherNumAtRisk': 40, 'otherNumAffected': 19, 'seriousNumAtRisk': 40, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Identical placebo given nightly for 12 months', 'otherNumAtRisk': 41, 'otherNumAffected': 17, 'seriousNumAtRisk': 41, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Infection not assumed related to study medicine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'Planned operation', 'notes': 'Pre-planned operation of known musculoskeletal or cardiac complaints not related to the study.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Bone Mineral Density (BMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Melatonin1+3', 'description': '1+3 mg melatonin nightly\n\nMelatonin: 1 or 3 mg of melatonin PO each night for 12 months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identical placebo given nightly\n\nMelatonin: 1 or 3 mg of melatonin PO each night for 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '2.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value was calculated', 'groupDescription': 'The p-value was calculated', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and end of study (after 12 months)', 'description': 'Effects of melatonin on BMD will be assessed through DXA-scans', 'unitOfMeasure': 'percentage of change in BMD', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Calcium Homeostasis', 'timeFrame': 'baseline, after 3, 6, 9 months, and end of study (after 12 months)', 'description': 'Calcium homeostasis will be analyzed through blood and urines samples', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Melatonin1+3', 'description': 'Melatonin: 1 or 3 mg of melatonin PO each night for 12 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Identical placebo given nightly for 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'We recruited 81 postmenopausal women with osteopenia to receive either melatonin (n=40) (1 or 3 mg) or similar placebo (n=41) nightly for 12 months. In addition, all women received a daily supplementation with 800mg calcium and 20ug D3', 'preAssignmentDetails': 'A total of 202 women were invited to participate. 81 were included in the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Melatonin1+3', 'description': 'Melatonin: 1 or 3 mg of melatonin PO each night for 12 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Identical placebo given nightly for 12 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2012-06-28', 'resultsFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2012-09-17', 'lastUpdatePostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-31', 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Bone Mineral Density (BMD)', 'timeFrame': 'baseline and end of study (after 12 months)', 'description': 'Effects of melatonin on BMD will be assessed through DXA-scans'}], 'secondaryOutcomes': [{'measure': 'Changes in Calcium Homeostasis', 'timeFrame': 'baseline, after 3, 6, 9 months, and end of study (after 12 months)', 'description': 'Calcium homeostasis will be analyzed through blood and urines samples'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '26424587', 'type': 'DERIVED', 'citation': 'Amstrup AK, Sikjaer T, Mosekilde L, Rejnmark L. The effect of melatonin treatment on postural stability, muscle strength, and quality of life and sleep in postmenopausal women: a randomized controlled trial. Nutr J. 2015 Sep 30;14:102. doi: 10.1186/s12937-015-0093-1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the effect of melatonin treatment in patients with osteopenia on BMD, muscle function, quality of life and calcium homeostasis.', 'detailedDescription': 'Background: Melatonin is known for its regulation of circadian rhythm. The production falls with age, which explains why elderly may have disturbed sleep patterns. Laboratory study and animal experimental studies suggests that melatonin also may protect against bone loss through increased osteoblast- and inhibited osteoclast activity. However, so far human studies have not been performed.\n\nDesign and patients: Double blinded randomised controlled study. Eighty post-menopausal women (aged 55-75) with osteopenia are randomized to receive 1mg, 3mg or placebo (daily - at night time) for 12 months.\n\nMethods and results: Effects of melatonin on BMD, bone- structure and mass will be assessed through DXA-scans, pQCT, and QCT. Quality of life, sleep, and activity level will be assessed though questionnaires. Calcium homeostasis will be analyzed through blood and urines samples. As safety parameters, balance and muscle function will also be performed.\n\nConclusion: Expected improvements in BMD, quality of life and sleep.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women between 55 and 75 years.\n* Osteopenia verified by DXA-scans of total hip or lumbar spine (t-score between -1 and -2.5)\n* Written informed consent after oral and written information\n\nExclusion Criteria:\n\n* Severely impaired renal function (plasma creatinine \\>60 eGFR ml/l).\n* Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) and/or alkaline phosphatase more the doubled compared to upper limit of reference value).\n* Coagulation factors PP \\<0.6\n* Hypercalcemia (p-ion calcium \\> 1.32 nmol/l)\n* Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy).\n* Diseases affecting the calcium homeostasis including untreated thyroid diseases.\n* Regular use of medicine affecting the calcium homeostasis; including diuretics, lithium, antiepileptica, glucosteroids.\n* SSRI-product with fluvoxamin.\n* Treatment with carbamazepin\n* Treatment with rifampicin\n* Severe malabsorption syndrome including gastric or intestinal resection.\n* Alcohol or drug abuse.\n* Smokers\n* Major medical or social problems that will be likely to preclude participation for one year.'}, 'identificationModule': {'nctId': 'NCT01690000', 'acronym': 'MelaOst', 'briefTitle': 'Treatment of Osteopenia With Melatonin', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Treatment of Osteopenia With Melatonin: Effects on BMD, Muscle Strength and Quality of Life', 'orgStudyIdInfo': {'id': '2011-AKA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin1', 'description': '1 mg melatonin nightly', 'interventionNames': ['Drug: Melatonin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Melatonin3', 'description': '3 mg melatonin given nightly', 'interventionNames': ['Drug: Melatonin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Identical placebo given nightly', 'interventionNames': ['Drug: Melatonin']}], 'interventions': [{'name': 'Melatonin', 'type': 'DRUG', 'description': '1 or 3 mg of melatonin PO each night for 12 months', 'armGroupLabels': ['Melatonin1', 'Melatonin3', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Osteoporoseklinikken, dept of Endocrinology and Internal Medicine (MEA)', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Anne Kristine Amstrup, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osteoporoseklinikken, Dept. of Endocrinology and Internal Medicine (MEA) Aarhus University Hospital, Tage-Hansens Gade 2, AArhus, DEnmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}