Nctid:
NCT00000400
Payload:
{"FullStudy"=>{"Rank"=>474909, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 06, 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"=>"M4831", "ConditionBrowseLeafName"=>"Bone Resorption", "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"=>"D000019379", "InterventionMeshTerm"=>"Teriparatide"}, {"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"=>"M21039", "InterventionBrowseLeafName"=>"Teriparatide", "InterventionBrowseLeafAsFound"=>"Hemophilia", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M21043", "InterventionBrowseLeafName"=>"Alendronate", "InterventionBrowseLeafAsFound"=>"Blood sampling", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M12884", "InterventionBrowseLeafName"=>"Parathyroid Hormone", "InterventionBrowseLeafAsFound"=>"g/L", "InterventionBrowseLeafRelevance"=>"high"}, {"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 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"176"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"August 1999"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2013", "CompletionDateStruct"=>{"CompletionDate"=>"June 2006", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 6, 2013", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 9, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"April 2006", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"change in spine bone mineral density", "PrimaryOutcomeTimeFrame"=>"study months 30 (phase A), 42 (phase B), 54 (phase C)"}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"change in hip bone mineral density", "SecondaryOutcomeTimeFrame"=>"study months 30 (phase A), 42 (phase B), 54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"change in forearm bone mineral density", "SecondaryOutcomeTimeFrame"=>"study months 30 (phase A), 42 (phase B), 54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"change in total body bone mineral", "SecondaryOutcomeTimeFrame"=>"study months 30 (phase A), 42 (phase B), 54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"change in femoral shaft bone mineral density", "SecondaryOutcomeTimeFrame"=>"study months 30 (phase A), 42 (phase B), 54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"change in serum PINP", "SecondaryOutcomeTimeFrame"=>"study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"change in serum osteocalcin", "SecondaryOutcomeTimeFrame"=>"study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"change in serum NTX", "SecondaryOutcomeTimeFrame"=>"study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"incidence of hypercalcemia", "SecondaryOutcomeTimeFrame"=>"study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"incidence of hypercalciuria", "SecondaryOutcomeTimeFrame"=>"study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)"}, {"SecondaryOutcomeMeasure"=>"incidence of symptoms", "SecondaryOutcomeTimeFrame"=>"study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)"}]}}, "OversightModule"=>{"OversightHasDMC"=>"Yes"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Osteoporosis", "Bone formation", "Bone resorption", "Parathyroid hormone (PTH)", "Postmenopause"]}, "ConditionList"=>{"Condition"=>["Osteoporosis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"19401368", "ReferenceType"=>"derived", "ReferenceCitation"=>"Finkelstein JS, Wyland JJ, Leder BZ, Burnett-Bowie SM, Lee H, Juppner H, Neer RM. Effects of teriparatide retreatment in osteoporotic men and women. J Clin Endocrinol Metab. 2009 Jul;94(7):2495-501. doi: 10.1210/jc.2009-0154. Epub 2009 Apr 28."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"http://www.mgh.harvard.edu", "SeeAlsoLinkLabel"=>"Click here for more information about this study."}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.", "DetailedDescription"=>"This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).\n\nParticipants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.\n\nParticipants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.\n\nDuring Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"85 years", "MinimumAge"=>"45 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nLumbar spine or hip BMD T-score less than or equal to minus 2.0\nPostmenopausal at least 5 years\nFully ambulatory\nAble to give informed consent\n\nExclusion Criteria:\n\nNo concurrent illnesses that cause bone loss\nNo recent drug treatment for osteoporosis\nNo recent fracture"}, "IdentificationModule"=>{"NCTId"=>"NCT00000400", "BriefTitle"=>"Alendronate and/or Parathyroid Hormone for Osteoporosis", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Massachusetts General Hospital"}, "OfficialTitle"=>"Bone Formation-Resorption Coupling and Osteoporosis", "OrgStudyIdInfo"=>{"OrgStudyId"=>"P50 AR44855 NIAMS-023"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"P50AR044855", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/P50AR044855", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"PTH", "ArmGroupDescription"=>"Human parathyroid hormone [hPTH-(1-34)]", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Human parathyroid hormone [hPTH-(1-34)]"]}}, {"ArmGroupType"=>"Active Comparator", "ArmGroupLabel"=>"ALN", "ArmGroupDescription"=>"Alendronate", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: alendronate"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"PTH+ALN", "ArmGroupDescription"=>"Human parathyroid hormone [hPTH-(1-34)] plus alendronate", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Human parathyroid hormone [hPTH-(1-34)]", "Drug: alendronate"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Human parathyroid hormone [hPTH-(1-34)]", "InterventionType"=>"Drug", "InterventionDescription"=>"37 mcg once daily by self-administered sc injection", "InterventionOtherNameList"=>{"InterventionOtherName"=>["teriparatide"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["PTH", "PTH+ALN"]}}, {"InterventionName"=>"alendronate", "InterventionType"=>"Drug", "InterventionDescription"=>"70 mg/week by oral route", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Fosamax"]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["ALN", "PTH+ALN"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"02114", "LocationCity"=>"Boston", "LocationState"=>"Massachusetts", "LocationCountry"=>"United States", "LocationFacility"=>"Massachusetts General Hospital"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Robert M. Neer, 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"=>"Physician", "ResponsiblePartyInvestigatorFullName"=>"Robert M. Neer, MD", "ResponsiblePartyInvestigatorAffiliation"=>"Massachusetts General Hospital"}}}}}}
