title: Lessons learned from an osteoporosis clinical trial in frail long-term care residents.
abstract: BACKGROUND
  Although osteoporosis affects women of all ages, the impact is most pronounced in frail residents in long-term care. Nevertheless, few interventional trials have been performed in this population, and few data on therapeutic alternatives are available in this cohort.
  
  
  OBJECTIVE
  We describe the challenges and lessons learned in developing and carrying out a trial in frail long-term-care residents.
  
  
  METHODS
  The Zoledronic acid in frail Elders to STrengthen bone (ZEST) study was designed to examine the safety and efficacy of a single-dose therapy for osteoporosis in frail residents in long-term care in the Pittsburgh area. Women with osteoporosis who were 65 years of age and older and currently not on therapy were randomized in a blinded fashion to intravenous zoledronic acid or placebo. Follow-up of each participant was planned for 2 years. All participants received appropriate calcium and vitamin D supplementation.
  
  
  RESULTS
  Seven hundred and thirty-three contacts were made with long-term care residents of nine participating facilities. Of 252 women screened, 181 were eligible, enrolled, and randomized. Multiple barriers to research in long-term-care facilities were encountered but overcome with direct communication, information sessions, in-service trainings, and social events. Lessons learned included designing the study in a manner that avoided placing an additional burden on an already overcommitted facility staff, a two-stage consent process to separate screening from randomization, and a flexible examination schedule to accommodate residents while obtaining the necessary outcome measurements. Furthermore, a mobile unit accessible to participants containing state-of-the-art dual x-ray absorptiometry (DXA), assessment for vertebral fractures, and phlebotomy equipment allows all assessments to be performed on-site at each facility. Serious adverse events are collected from affiliated hospitals in real time with a novel electronic surveillance system.
  
  
  CONCLUSIONS
  The major limitation is selection of outcomes that can be assessed at participating facilities and do not require transport of participants to hospitals or clinics.
  
  
  CONCLUSIONS
  Clinical research for osteoporosis can be successfully and safely performed with frail residents in long-term care facilities. Lessons learned from this study may inform future investigations among frail elderly residents of these facilities.
authors.affiliation: Division of Endocrinology, University of Pittsburgh, Pittsburgh, PA 15213, USA. greenspn@pitt.edu
authors.forename: Sl
authors.initials: S
authors.lastname: Greenspan
authors.forename: D
authors.initials: D
authors.lastname: Nace
authors.forename: S
authors.initials: S
authors.lastname: Perera
authors.forename: M
authors.initials: M
authors.lastname: Ferchak
authors.forename: G
authors.initials: G
authors.lastname: Fiorito
authors.forename: D
authors.initials: D
authors.lastname: Medich
authors.forename: K
authors.initials: K
authors.lastname: Zukowski
authors.forename: D
authors.initials: D
authors.lastname: Adams
authors.forename: C
authors.initials: C
authors.lastname: Lee
authors.forename: M
authors.initials: M
authors.lastname: Saul
authors.forename: Nm
authors.initials: N
authors.lastname: Resnick
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use; D004164:Diphosphonates / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D016330:Frail Elderly; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy*; D018579:Patient Selection; D010414:Pennsylvania; D012112:Residential Facilities; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid