Nctid:
NCT00000427
Payload:
{"FullStudy"=>{"Rank"=>474467, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000010024", "ConditionMeshTerm"=>"Osteoporosis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001851", "ConditionAncestorTerm"=>"Bone Diseases, Metabolic"}, {"ConditionAncestorId"=>"D000001847", "ConditionAncestorTerm"=>"Bone Diseases"}, {"ConditionAncestorId"=>"D000009140", "ConditionAncestorTerm"=>"Musculoskeletal Diseases"}, {"ConditionAncestorId"=>"D000008659", "ConditionAncestorTerm"=>"Metabolic Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M12637", "ConditionBrowseLeafName"=>"Osteoporosis", "ConditionBrowseLeafAsFound"=>"Osteoporosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17944", "ConditionBrowseLeafName"=>"Osteoporosis, Postmenopausal", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4820", "ConditionBrowseLeafName"=>"Bone Diseases, Metabolic", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4816", "ConditionBrowseLeafName"=>"Bone Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11787", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11329", "ConditionBrowseLeafName"=>"Metabolic Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"Nutritional and Metabolic Diseases", "ConditionBrowseBranchAbbrev"=>"BC18"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000019386", "InterventionMeshTerm"=>"Alendronate"}, {"InterventionMeshId"=>"D000006728", "InterventionMeshTerm"=>"Hormones"}, {"InterventionMeshId"=>"D000010281", "InterventionMeshTerm"=>"Parathyroid Hormone"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000006730", "InterventionAncestorTerm"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000050071", "InterventionAncestorTerm"=>"Bone Density Conservation Agents"}, {"InterventionAncestorId"=>"D000077264", "InterventionAncestorTerm"=>"Calcium-Regulating Hormones and Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M9479", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafAsFound"=>"Cisplatin", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M21043", "InterventionBrowseLeafName"=>"Alendronate", "InterventionBrowseLeafAsFound"=>"Chosen", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M12884", "InterventionBrowseLeafName"=>"Parathyroid Hormone", "InterventionBrowseLeafAsFound"=>"Once or twice", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3033", "InterventionBrowseLeafName"=>"Anabolic Androgenic Steroids", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9478", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5071", "InterventionBrowseLeafName"=>"Calcium", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5088", "InterventionBrowseLeafName"=>"Calcium, Dietary", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"81"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1999"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2013", "CompletionDateStruct"=>{"CompletionDate"=>"October 2005", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 6, 2013", "StudyFirstSubmitDate"=>"January 18, 2000", "StudyFirstSubmitQCDate"=>"January 18, 2000", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 9, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"January 19, 2000", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"October 2005", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Parathyroid Hormone (PTH)", "Alendronate", "Bone metabolism", "Bone mineral density (BMD)", "Bone loss", "Postmenopausal osteoporosis", "Osteoporosis in men"]}, "ConditionList"=>{"Condition"=>["Osteoporosis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"7969342", "ReferenceType"=>"background", "ReferenceCitation"=>"Finkelstein JS, Klibanski A, Schaefer EH, Hornstein MD, Schiff I, Neer RM. Parathyroid hormone for the prevention of bone loss induced by estrogen deficiency. N Engl J Med. 1994 Dec 15;331(24):1618-23. doi: 10.1056/NEJM199412153312404."}, {"ReferencePMID"=>"14500805", "ReferenceType"=>"background", "ReferenceCitation"=>"Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1216-26. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20."}, {"ReferencePMID"=>"16684825", "ReferenceType"=>"result", "ReferenceCitation"=>"Finkelstein JS, Leder BZ, Burnett SM, Wyland JJ, Lee H, de la Paz AV, Gibson K, Neer RM. Effects of teriparatide, alendronate, or both on bone turnover in osteoporotic men. J Clin Endocrinol Metab. 2006 Aug;91(8):2882-7. doi: 10.1210/jc.2006-0190. Epub 2006 May 9."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.", "DetailedDescription"=>"Osteoporosis causes bones to weaken and break more easily. Alendronate is used to treat or prevent osteoporosis. PTH is a protein hormone that increases the calcium and phosphorus release from bone, leading to formation of new bone. This study will examine the changes in bone density measured at multiple places in the skeleton and changes in chemicals in the body that indicate bone breakdown and bone formation. The study will indicate whether some breakdown of bone is required for PTH to have an overall bone-building effect in men.\n\nParticipants will be randomly assigned to receive PTH alone by daily injection under the skin, alendronate alone taken by mouth, or both PTH and alendronate. The study will last 2.5 years. All participants will receive some form of treatment for osteoporosis. Blood, urine, and bone density tests will be performed at 6-month intervals. During the first 6 months, participants will come in for additional study visits.\n\nParticipants who complete the initial 2.5 years of their assigned treatment will be eligible for a 12 month extension to monitor bone density and bone turnover after PTH is stopped. Participants who were receiving alendronate will continue taking alendronate. The goal of this extension is to determine what happens to bone density and turnover after PTH is stopped and whether alendronate is needed to prevent loss of PTH-induced bone gain.\n\nParticipants who complete the 12 month extension while on their assigned treatment will be eligible for a second 12 month extension in which all participants receive PTH therapy. Participants who have been receiving alendronate continue taking alendronate. The goal of the second extension is to determine if responsiveness to PTH is enhanced by a 12 month suspension of PTH treatment."}, "EligibilityModule"=>{"Gender"=>"Male", "MaximumAge"=>"85 years", "MinimumAge"=>"46 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nBone density of the spine or femoral neck two standard deviations below the mean of young adult men\nNormal renal and liver function tests, normal serum testosterone level, normal vitamin D and PTH levels\n\nExclusion Criteria:\n\nSignificant cardiac, renal, hepatic, or malignant disease.\nDisorders (e.g., Paget's disease, hyperthyroidism, hyperparathyroidism) or drugs (e.g., steroids, anticonvulsants, lithium, bisphosphonates, calcitonin, fluoride) known to affect bone metabolism\nActive peptic ulcer disease or severe reflux"}, "IdentificationModule"=>{"NCTId"=>"NCT00000427", "BriefTitle"=>"Effects of Parathyroid Hormone in Men With Osteoporosis", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Massachusetts General Hospital"}, "OfficialTitle"=>"Anabolic Actions of Parathyroid Hormone in Osteoporotic Men", "OrgStudyIdInfo"=>{"OrgStudyId"=>"P50AR044855", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/P50AR044855", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"P50AR044855", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/P50AR044855", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"NIAMS-015"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Parathyroid hormone", "InterventionType"=>"Drug"}, {"InterventionName"=>"Alendronate", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"02114", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Massachusetts General Hospital"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Joel S. Finkelstein, MD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Massachusetts General Hospital"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Massachusetts General Hospital", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"Associate Professor of Medicine", "ResponsiblePartyInvestigatorFullName"=>"Joel S. Finkelstein, MD", "ResponsiblePartyInvestigatorAffiliation"=>"Massachusetts General Hospital"}}}}}}
