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Prevention of Fractures in Patients with Parkinson's Disease

帕金森病患者骨折的预防

基本信息

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
项目类别：
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

项目摘要

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.

帕金森氏症（PD）患者骨折的风险非常高：大约是所有患者的2到3倍