Prevention of Fractures in Patients with Parkinson's Disease

帕金森病患者骨折的预防

• 批准号: 10617169
• 负责人: STEVEN RON CUMMINGS
• 金额: $ 319.24万
• 依托单位: CALIFORNIA PACIFIC MED CTR RES INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10617169
• 关键词: Acids; Address; Age; Binding; Blinded; Bone Density; Bone remodeling; Calcium; Cessation of life; Clinic Visits; Clinical; Communities; Data; Diagnosis; Documentation; Enrollment; Evaluation; Foundations; Fracture; Guidelines; Health system; Hip Fractures; Home; Infusion procedures; Institutional Review Boards; Intravenous; Medical; Monitor; Movement Disorders; Neurologist; Nursing Research; Oral; Osteoporosis; Parkinson Disease; Patient Care; Patients; Pharmaceutical Preparations; Placebo Control; Placebos; Prevention; Recovery of Function; Research Design; Risk; Risk Reduction; Specialist; Subgroup; Surveys; Telemedicine; Testing; Uncertainty; Visit; Vitamin D supplementation; Woman; Zoledronic Acid; barrier to care; bisphosphonate; bone; bone loss; clinical diagnosis; design; diaries; economic evaluation; efficacy testing; efficacy trial; experience; fall risk; falls; follow-up; fracture risk; health economics; high risk; human old age (65+); improved; men; mortality; non-compliance; older patient; pelvis fracture; pharmacologic; population based; preservation; prevent; primary endpoint; randomized placebo controlled trial; randomized trial; recruit; safety assessment; screening; secondary endpoint; treatment response

Patients with Parkinson's disease (PD) have a very high risk of fracture: about 2 to 3-fold increased risk of all fractures and 4-fold increased risk of hip fracture that may be due in large part to their very high risk of multiple falls. Compared with other patients who suffer fractures, PD patients have more severe consequences of fractures: they have twice the risk of dying following hip and pelvic fractures and longer and incomplete functional recovery, with worsening of Parkinson's disease. Crucially, men and women age 65 or older have a fracture risk that is so high, that even those with normal bone density (BMD) for age would warrant a therapy that has been proven to reduce fracture risk in patients with PD. However, very few PD patients age 65 of older receive a treatment for osteoporosis. There are several major barriers to treatment of PD patients with drugs for osteoporosis. 1) There is a lack of evidence that treatments reduce fracture risk in patients with PD whose risk of fractures may be due to multiple and more severe falls. 2) Standard osteoporosis screening and treatment may also be a barrier. Medical visits to assess fracture risk, test BMD, prescribe treatment, generally an oral drug, and then follow-up to monitor compliance and response to treatment, are particularly burdensome for patients with PD. 3) Most patients with PD do not continue taking oral osteoporosis drugs even for 1 year. We propose a randomized trial that addresses all of these barriers. 1) We will test the anti-fracture efficacy of Zoledronic acid (ZA) a very potent bisphosphonate that inhibits bone loss and decreased fracture risk in women with osteoporosis and patients with hip fractures. 2) We will give ZA intravenously at home without clinic visits. 3) ZA inhibits bone loss for at least 2 years overcoming noncompliance with oral drugs. We will enroll 3,500 men and women PD age 65 years or older from large health systems, patient communities, and referrals from neurologists in the Parkinson's Study Group. A movement disorders specialist will confirm the diagnosis of PD by telemedicine. We will then provide calcium and vitamin D supplements. A research nurse will visit the patient at home, check for potential contraindications to ZA and then administer IV ZA or placebo. We will then follow patients for 2 years to ascertain and confirm fractures. A successful result may revolutionize the care of patients with PD. It may lead to guidelines promoting home-based ZA treatment of older PD patients. ZA, rather than oral drugs, would become the 1st line treatment for patients with PD. The trial would demonstrate that home-based treatment with ZA, without other assessments, could reach all older PD patients without the need for burdensome medical visits. Thus, a positive result may lead to treatment of many more PD patients and a substantial reduction in the occurrence of disabling fractures in patients with PD.

帕金森氏病(PD)患者有很高的骨折风险：ALL的风险增加约2到3倍 骨折和髋部骨折风险增加4倍，这在很大程度上可能是由于他们非常高的多发性 瀑布。与其他骨折患者相比，帕金森病患者的后果更严重 骨折：他们死于髋部和骨盆骨折的风险是髋部和骨盆骨折的两倍，而且时间更长且不完全 功能恢复，帕金森氏病恶化。至关重要的是，65岁或65岁以上的男性和女性 骨折的风险如此之高，以至于即使那些年龄的骨密度(BMD)正常的人也需要治疗 这已被证明可以降低帕金森病患者的骨折风险。 然而，65岁以上的帕金森病患者很少接受骨质疏松症的治疗。有几个主要的 帕金森病患者骨质疏松症药物治疗的障碍。1)缺乏证据表明治疗方法 降低帕金森病患者的骨折风险，这些患者的骨折风险可能是由于多次和更严重的跌倒造成的。2) 标准的骨质疏松症筛查和治疗也可能是一个障碍。就诊以评估骨折风险， 检测骨密度，开出治疗处方，通常是口服药物，然后进行随访，监测依从性和反应 对于帕金森病患者来说，治疗是特别繁重的。3)大多数帕金森病患者不再继续服用 口服骨质疏松症药物甚至1年。 我们建议进行一项随机试验，以解决所有这些障碍。1)我们将测试其抗骨折效果 唑来膦酸(ZA)是一种非常有效的双膦酸盐，可以抑制骨丢失和降低骨折风险 患有骨质疏松症的妇女和髋部骨折患者。2)我们将在家中静脉注射ZA，而不是 去诊所就诊。3)ZA可抑制骨丢失至少2年，克服口服药物的不顺应性。我们会 招募3,500名65岁或以上的男性和女性PD患者，来自大型医疗系统、患者社区和 帕金森研究小组神经科医生的推荐。一名运动障碍专家将确认 远程医疗诊断帕金森病。然后我们将提供钙和维生素D补充剂。一名研究护士 将在家中探望患者，检查ZA的潜在禁忌症，然后使用静脉ZA或安慰剂。 然后我们将对患者进行2年的跟踪调查，以确定和确认骨折。 一个成功的结果可能会使帕金森病患者的护理发生革命性变化。它可能会导致指导方针促进 老年帕金森病患者的家庭ZA治疗。ZA，而不是口服药物，将成为一线治疗 为帕金森病患者准备的。这项试验将证明，在没有其他药物的情况下，使用ZA进行家庭治疗 评估，可以覆盖所有老年帕金森病患者，而不需要繁琐的医疗访问。因此，一个 阳性结果可能会导致更多的帕金森病患者接受治疗，并大幅减少发病率 帕金森病患者致残骨折的可能性。