Preserving Geriatric Muscle with an Osteoporosis Medication
用骨质疏松症药物保护老年肌肉
基本信息
- 批准号:10633791
- 负责人:
- 金额:$ 68.14万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-06-01 至 2028-05-31
- 项目状态:未结题
- 来源:
- 关键词:3-DimensionalActivities of Daily LivingAddressAdultAttenuatedBiochemicalBiochemical PathwayBone DensityCalendarCessation of lifeCommunicationCommunitiesControlled Clinical TrialsCreatineDependenceDistalDouble-Blind MethodElderlyElectronicsEnrollmentEventFaceFall preventionFractureFrail ElderlyGDF8 geneGoalsHand StrengthHealthHip FracturesHip region structureHospitalizationIncidenceIndividualInstitutionalizationKneeKnowledgeLinkLong-Term CareMeasuresMechanicsMediatingMedical Care CostsMeta-AnalysisMolecular TargetMonitorMorbidity - disease rateMulticenter TrialsMuscleMuscle functionMuscular AtrophyN-terminalNotificationOralOsteocalcinOsteopeniaOsteoporosisOutcomeParticipantPathway interactionsPatientsPeptidesPersonal SatisfactionPharmaceutical PreparationsPhysical FunctionPilot ProjectsPolypharmacyPopulationPreventionPrevention strategyPrevention trialProcollagen Type IIIQuality of lifeRandomizedReportingResearchResearch PersonnelSafetySerious Adverse EventSiteSoft Tissue DisorderSpinal FracturesStructureSyndromeSystemTechniquesTelephoneTimeTranslatingVulnerable PopulationsWomanZoledronic Acidabsorptionadverse outcomeage groupbonebone healthbone lossbone masscohortcomorbiditycomparison controldisabilityefficacy evaluationefficacy testingfall riskfallsfrailtyfunctional outcomeshigh riskhuman old age (65+)improvedinnovationmenmortalitymuscle strengthneglectnovelnovel strategiesolder menolder womenosteoporosis with pathological fractureportabilitypreservationpreventprimary outcomepublic health relevancereduced muscle masssarcopeniasedentaryskeletalstatisticssuccesssymposiumultrasound
项目摘要
Approximately one third of older adults in senior communities fall each year, and falls are the leading cause of
morbidity and mortality in this age group. Falls are associated with poor quality of life, disability, and death; the
medical cost is over $30 billion annually. Despite these statistics, fall reduction strategies have had limited
impact for frail seniors. The most devastating fall-related outcome is a hip or other fracture. Over 90% of hip
and nonvertebral fractures occur from a fall, and approximately 85% of long-term care (LTC) residents have
osteoporosis. Recently, investigators have reported cross-talk between muscle and bone through mechanical
and biochemical pathways. Osteosarcopenia, a newly described geriatric syndrome, involves the coexistence
of osteoporosis (low bone mass) and sarcopenia (low muscle mass/function). The coexistence of these
conditions puts patients at even greater risk for fall/fracture-related serious adverse outcomes. Denosumab
(DEMAB), a medication approved for osteoporosis, acts on molecular targets shared between muscle and
bone. In the DEMAB pivotal trial and a meta-analysis in healthy adults, investigators reported a reduction in
recalled falls in addition to a decrease in fractures. Therefore, DEMAB has the potential to reduce both falls
and fractures in a vulnerable population at high risk for both events. Our goal is to demonstrate efficacy of
the novel agent DEMAB to improve or preserve muscle health, strength, mobility and function in frail older
adults. If successful, this would lay the groundwork for a larger multicenter trial to examine the dual-action for
fall and fracture prevention. To bridge this knowledge gap we propose to conduct a 1-year, randomized,
double-blind, active-controlled trial to test the efficacy of DEMAB (expected active muscle agent) versus
zoledronic acid (ZOL, muscle control) in 248 underserved, LTC, frail institutionalized men and women (age≥65)
with osteoporosis. Muscle strength, power, quality, markers, function and bone measures will be collected in a
mobile lab. At trial completion, all participants receive ZOL for osteoporosis therapy and to prevent potential
bone loss following DEMAB discontinuation. Our objectives include Aim 1: Evaluate efficacy of DEMAB to
preserve/improve muscle strength, power, mass and structure. Aim 2: Examine the mechanistic
biochemical components of the muscle-bone connection. Aim 3: Explore if the DEMAB effect extends
to distal functional outcomes. This study includes a number of innovative features: 1) focus on the
neglected LTC population of frail older men and women in whom we have a track record of successful
enrollment, 2) inclusion of an approved osteoporosis agent feasible in the LTC setting with a novel focus on
muscle strength, power, structure, and function, 3) mobile lab allowing onsite participation, 4) assessment
of muscle and bone parameters by portable techniques, and 5) electronic alerts for falls and SAEs. This study
will challenge the current paradigm of avoiding anti-fracture/fall therapy in vulnerable fallers and establish the
necessary conditions to justify a large trial to maintain muscle and bone health to reduce falls and fractures.
在老年社区中,每年大约有三分之一的老年人跌倒,而跌倒是导致死亡的主要原因
项目成果
期刊论文数量(0)
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SUSAN L GREENSPAN其他文献
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{{ truncateString('SUSAN L GREENSPAN', 18)}}的其他基金
Maintenance of Skeletal Integrity in Frail Elders-Phase 2
维持体弱老年人骨骼完整性第二阶段
- 批准号:
8983884 - 财政年份:2015
- 资助金额:
$ 68.14万 - 项目类别:
Maintenance of Skeletal Integrity in Frail Elders
维持体弱老年人骨骼的完整性
- 批准号:
7678235 - 财政年份:2007
- 资助金额:
$ 68.14万 - 项目类别:
Maintenance of Skeletal Integrity in Frail Elders
维持体弱老年人骨骼的完整性
- 批准号:
7587990 - 财政年份:2007
- 资助金额:
$ 68.14万 - 项目类别:
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