{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T16:28:41Z","timestamp":1785774521688,"version":"3.56.0"},"reference-count":29,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2011,12,7]],"date-time":"2011-12-07T00:00:00Z","timestamp":1323216000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2012,4]]},"abstract":"<jats:p>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.<\/jats:p>\n                  <jats:p>Purpose We describe the challenges and lessons learned in developing and carrying out a trial in frail long-term-care residents.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>Limitations 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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1177\/1740774511430516","type":"journal-article","created":{"date-parts":[[2011,12,8]],"date-time":"2011-12-08T00:09:30Z","timestamp":1323302970000},"page":"247-256","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":24,"title":["Lessons learned from an osteoporosis clinical trial in frail long-term care residents"],"prefix":"10.1177","volume":"9","author":[{"given":"SL","family":"Greenspan","sequence":"first","affiliation":[{"name":"Division of Endocrinology, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Nace","sequence":"additional","affiliation":[{"name":"Division of Geriatrics, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S","family":"Perera","sequence":"additional","affiliation":[{"name":"Division of Geriatrics, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Ferchak","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G","family":"Fiorito","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Medich","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K","family":"Zukowski","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D","family":"Adams","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M","family":"Saul","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"NM","family":"Resnick","sequence":"additional","affiliation":[{"name":"Division of Geriatrics, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2011,12,7]]},"reference":[{"key":"bibr1-1740774511430516","doi-asserted-by":"publisher","DOI":"10.1007\/s001980050129"},{"key":"bibr2-1740774511430516","doi-asserted-by":"publisher","DOI":"10.1111\/j.1532-5415.1993.tb06452.x"},{"key":"bibr3-1740774511430516","doi-asserted-by":"publisher","DOI":"10.1007\/BF02555097"},{"key":"bibr4-1740774511430516","doi-asserted-by":"publisher","DOI":"10.1097\/00001648-199103000-00005"},{"issue":"1","key":"bibr5-1740774511430516","first-page":"1","volume":"16","author":"Anonymous","year":"2000","journal-title":"Osteoporos 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