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.

帕金森病（PD）患者骨折的风险非常高：所有患者的风险增加约2至3倍。 骨折和4倍增加髋部骨折的风险，这可能在很大程度上是由于他们非常高的风险， 福尔斯。与其他遭受骨折的患者相比，PD患者有更严重的后果， 骨折：他们在髋部和骨盆骨折后死亡的风险是其他人的两倍， 功能恢复，帕金森病恶化。重要的是，65岁或以上的男性和女性有一个 骨折的风险是如此之高，即使是那些正常的骨密度（BMD）的年龄将保证治疗 已被证明可以降低PD患者的骨折风险。 然而，很少有65岁以上的PD患者接受骨质疏松症的治疗。有几大 使用骨质疏松症药物治疗PD患者的障碍。1)没有证据表明治疗 降低PD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福尔斯跌倒所致。（二） 标准的骨质疏松症筛查和治疗也可能是一个障碍。进行医疗访问以评估骨折风险， 测试骨密度，开处方治疗，通常是口服药物，然后随访以监测依从性和反应 对于PD患者来说，治疗尤其困难。3)大多数PD患者不继续服用 口服骨质疏松药物甚至1年。 我们提出了一个随机试验，解决所有这些障碍。1)我们将测试 唑来膦酸（ZA）是一种非常有效的双膦酸盐，可抑制骨丢失并降低骨折风险， 骨质疏松症妇女和髋部骨折患者。2)我们将在家中静脉注射ZA， 诊所访问。3)ZA抑制骨丢失至少2年，克服口服药物的不依从性。我们将 从大型卫生系统、患者社区招募3，500名65岁或以上的男性和女性PD， 帕金森病研究小组的神经科医生的推荐。运动障碍专家会确认 通过远程医疗诊断PD。然后我们将提供钙和维生素D补充剂。研究护士 将在家中访问患者，检查ZA的潜在禁忌症，然后IV ZA或安慰剂给药。 然后，我们将对患者进行为期2年的随访，以确定并确认骨折。 一个成功的结果可能会彻底改变PD患者的护理。这可能会导致指导方针， 老年PD患者的家庭ZA治疗。ZA，而不是口服药物，将成为一线治疗 对于PD患者。该试验将证明，在没有其他药物的情况下， 评估，可以达到所有老年PD患者，而不需要繁琐的医疗访问。因此 阳性结果可能会导致更多的PD患者接受治疗，并大幅降低PD的发生率。 残疾性骨折的风险