Calculator for Length of Use of Bisphosphonates (CLUB)
双膦酸盐使用期限计算器 (CLUB)
基本信息
- 批准号:10515879
- 负责人:
- 金额:$ 125.14万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-15 至 2027-06-30
- 项目状态:未结题
- 来源:
- 关键词:AddressAdultAreaBenefits and RisksBone necrosisCalibrationCaliforniaCaringClinicalClinical TrialsCommunitiesDataDecision MakingDiscriminationDrug usageDual-Energy X-Ray AbsorptiometryEducational workshopElderlyEnsureEthnic OriginExcess MortalityFemoral FracturesFractureGuidelinesHealthHealth BenefitHealth Care CostsHealth care facilityHealthcare SystemsHolidaysIndividualInternetIntravenousJawLengthLong-Term CareMeasuresMid-Atlantic RegionMinnesotaModelingMorbidity - disease rateNursing HomesOnline SystemsOralOsteoporosisOutcomePathway interactionsPatientsPersonsPharmaceutical PreparationsPharmacotherapyPopulationPopulation HeterogeneityPostmenopausePreventionPrevention therapyProfessional OrganizationsPublic HealthQuality of lifeRaceRecommendationRecording of previous eventsReportingRiskRisk EstimateRisk FactorsSafetySex DifferencesSiteTherapeuticTimeUnited States National Institutes of HealthValidationVeterans Health AdministrationVoiceWomanadministrative databasealternative treatmentbasebisphosphonateburden of illnesscohortcommunity livingcomorbiditycost effectivecost effectivenessdesignethnic differencefracture riskhigh riskmedication safetymenmortalitymultidisciplinaryolder patientosteoporosis with pathological fracturepatient populationpoint of carepopulation basedprediction algorithmpreventracial differencerisk benefit ratiosexshared decision makingside effecttooltreatment duration
项目摘要
Osteoporotic fractures are a major public health problem, especially for older persons.
Bisphosphonates (BPs) are an inexpensive therapeutic class of drugs effective at preventing
these fractures. However, there has been a substantial decline in use of BPs for osteoporosis at
least in part because of concerns for rare, albeit potentially serious side effects, namely atypical
femoral fractures (AFF) and bisphosphonate medication related osteonecrosis of the jaw
(MRONJ). Duration of treatment is a risk factor for long-term side effects from BPs, including
AFF, and to a lesser extent, MRONJ. To assist with decision-making regarding duration of use
of BPs, the FDA and professional societies developed guidelines suggesting that after three to
five years of oral or three years of intravenous BP use, that reassessment of fracture risk with
possible provision of a drug holiday be done. However, these recommendations were based on
very limited evidence largely derived from white, healthy, community-dwelling postmenopausal
women. Moreover, the risk associated with drug holidays is uncertain, as emerging reports
suggest that a number of women have sustained osteoporotic fractures while off therapy. It is
paramount to better understand the risk-benefit profile of long-term BP therapy and drug
holidays, in both men and women, all races and ethnicities, and those with serious
comorbidities. To accomplish this, we have amassed an expert multidisciplinary team to study
large and diverse patient populations ranging from community dwelling to long-term care
residents from Kaiser Permanente (KP; Northern California, Georgia, and Mid-Atlantic regions),
Health Partners (HP; Minnesota), and the national Veterans Health Administration (VHA),
spanning 30 years (1996 to 2025) and including over half a million older U.S. adults who
initiated osteoporosis treatment with a BP. Utilizing this population, we will determine risks and
benefits, health care costs and cost effectiveness of uninterrupted continuation of BPs versus
BP drug holidays. These information will be utilized to develop a risk factor calculator to
determine if a drug holiday should be done (Calculator for Length of use of Bisphosphonates
(CLUB)). An expert panel including both clinician and consumer voices will inform the final
design of CLUB. We anticipate that CLUB will be a clinically useful point-of-care tool to guide
shared decision-making on BP use and optimize care for older patients at risk for fracture.
骨质疏松性骨折是一个重大的公共卫生问题,特别是对于老年人而言。
双膦酸盐 (BP) 是一种廉价的治疗药物,可有效预防
这些骨折。然而,BP 治疗骨质疏松症的使用量大幅下降
至少部分是因为担心罕见但可能严重的副作用,即非典型副作用
股骨骨折(AFF)和双膦酸盐药物相关的颌骨坏死
(莫龙杰)。治疗持续时间是 BP 产生长期副作用的危险因素,包括
AFF,以及较小程度上的 MRONJ。协助做出有关使用持续时间的决策
BP、FDA 和专业协会制定了指导方针,建议在三到
五年口服血压或三年静脉注射血压,重新评估骨折风险
可能会规定药物假期。然而,这些建议是基于
非常有限的证据主要来自白人、健康、社区居住的绝经后
女性。此外,正如新出现的报告所示,与药物假期相关的风险是不确定的
表明许多女性在停止治疗时患有骨质疏松性骨折。这是
对于更好地了解长期血压治疗和药物的风险效益至关重要
假期,无论男性还是女性,所有种族和民族,以及那些患有严重疾病的人
合并症。为了实现这一目标,我们组建了一个多学科专家团队来研究
从社区住宅到长期护理的大量且多样化的患者群体
来自 Kaiser Permanente(KP;北加州、佐治亚州和中大西洋地区)的居民,
健康合作伙伴(HP;明尼苏达州)和国家退伍军人健康管理局 (VHA),
跨越 30 年(1996 年至 2025 年),其中包括超过 50 万美国老年人
开始用 BP 治疗骨质疏松症。利用这个群体,我们将确定风险并
不间断持续 BP 的益处、医疗保健成本和成本效益与
BP 药物假期。这些信息将用于开发风险因素计算器
确定是否应该休药假(双膦酸盐使用时长计算器
(俱乐部))。包括临床医生和消费者声音在内的专家小组将告知最终结果
俱乐部的设计。我们预计 CLUB 将成为临床上有用的护理点工具来指导
共同制定血压使用决策并优化对有骨折风险的老年患者的护理。
项目成果
期刊论文数量(0)
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会议论文数量(0)
专利数量(0)
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{{ truncateString('LAURA D CARBONE', 18)}}的其他基金
Calculator for Length of Use of Bisphosphonates (CLUB)
双膦酸盐使用期限计算器 (CLUB)
- 批准号:
10700142 - 财政年份:2022
- 资助金额:
$ 125.14万 - 项目类别:
Best Practices for Management of Fractures in Spinal Cord Injuries and Disorders
脊髓损伤和疾病骨折管理的最佳实践
- 批准号:
10179490 - 财政年份:2017
- 资助金额:
$ 125.14万 - 项目类别:
Best Practices for Management of Fractures in Spinal Cord Injuries and Disorders
脊髓损伤和疾病骨折管理的最佳实践
- 批准号:
9293507 - 财政年份:2017
- 资助金额:
$ 125.14万 - 项目类别:
Best Practices for Management of Fractures in Spinal Cord Injuries and Disorders
脊髓损伤和疾病骨折管理的最佳实践
- 批准号:
10178106 - 财政年份:2017
- 资助金额:
$ 125.14万 - 项目类别:
Modeling fracture prediction in spinal cord injury and disease
脊髓损伤和疾病的骨折预测建模
- 批准号:
8396325 - 财政年份:2012
- 资助金额:
$ 125.14万 - 项目类别:
THE EFFECTS OF ATKINS VS TRADITIONAL DIET ON BONE
阿特金斯饮食与传统饮食对骨骼的影响
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7375442 - 财政年份:2005
- 资助金额:
$ 125.14万 - 项目类别:
EFFICACY OF TERIPARATIDE TREATMENT OF REDUCED BMD IN LIVER TRANSPLANT PATIENTS
特立帕肽治疗肝移植患者骨密度降低的疗效
- 批准号:
7375430 - 财政年份:2005
- 资助金额:
$ 125.14万 - 项目类别:
EFFICACY OF TERIPARATIDE TREATMENT OF REDUCED BMD IN LIVER TRANSPLANT PATIENTS
特立帕肽治疗肝移植患者骨密度降低的疗效
- 批准号:
7206684 - 财政年份:2004
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7206681 - 财政年份:2004
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$ 125.14万 - 项目类别:
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