Institutional Review Board, Hospital for Special Surgery
February 21, 2019
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Sebastian E. Sattui Cortes
Lindsay S. Lally, MD
The purpose of this study is to describe the process of frailty in patients with Polymyalgia Rheumatica (PMR). It will also examine the relationship between changes in body composition with weakness and frailty in PMR. Frailty is a process that can affect our ability to bounce back after an illness or other stressful events (such as a fall) as well as our ability to live independently ( examples: doing household chores, feeling a bit unsteady on our feet, keeping touch with our family and friends). Studies done in patients with other conditions have shown that frailty and changes in body composition can affect the quality of life in patients. This has not been described in PMR yet, but if recognized, this could be potentially treated. This could lead to improvements in quality of life. A total of 72 subj_ects will participate in this study at HSS. The study consists of two visits (initial visit and 12-month follow-up), which are composed of a physical exam, physical measures, and surveys/questionnaires. Also, during the initial visit, a DXA scan to asses body composition will be done. Enrollment and follow up will occur during 2019 and 2020.
• EULAR/ ACR PMR criteria
• Less than 6 months since the time of diagnosis
• Current treatment with prednisone equivalent of 5mg or higher
• Diagnosis of Giant Cell arteritis or seronegative rheumatoid arthritis
• Other rheumatologic condition ( except osteoarthritis)
• End stage renal disease
• Oxygen dependent COPD or secondary to other pulmonary condition
• Active malignancy or malignancy in <5 year other than squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ after curative treatment
• Post-transplant patients