Amgen_20170129_Osteoporosis
Research type
Research Study
Full title
Osteoporosis Diagnosis and Treatment in Community-dwelling Women ≥70 Years of Age Managed in Primary Care Setting in Europe. A Cross-Sectional Observational Study
IRAS ID
241933
Contact name
Amar Ali
Contact email
Sponsor organisation
Amgen Limited
Duration of Study in the UK
0 years, 5 months, 4 days
Research summary
Osteoporosis is characterised by reduced bone mass and disruption of bone structure, resulting in increased bone fragility and increased fracture risk. The hallmark of Osteoporosis is fragility fractures, caused by minor trauma during a fall from standing or a lesser height. Osteoporosis causes more than 8.9 million fractures annually worldwide.\n\nThe prevalence of Osteoporosis increases markedly with age and despite advances in the diagnosis, assessment, and treatment of Osteoporosis, only a minority of patients at high fracture risk are identified for treatment. \n\nThere is a large gap between the number of women who are treated compared with the proportion of the population that could be considered eligible for treatment based on their fracture risk.\n\nThis therapeutic care gap is wider in the elderly, in whom the importance and impact of treatment is high; studies have shown that as few as 10% of women with fragility fractures receive any Osteoporosis therapy. \n\nThis study will specifically focus on assessing this gap in women ≥70 years of age. Characterising this gap is important as the vast majority of fragility fractures occur in elderly women where clinical and health outcomes are significant at the individual and population level. \n\nThe primary aim of this study is to assess the proportion of subjects who are not receiving any Osteoporosis medication among those at risk of fragility fractures in a large sample of women ≥70 years of age attending a routine visit with their general practitioner (GP) regardless of the reason for consultation, between January 2018 and June 2018.\n\nStudy variables obtained from the patients medical record will be entered into the electronic case report form (eCRF) by the site staff. In addition, subjects will be asked to complete a short questionnaire. This observational study is not intended to alter the clinical management of subjects.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0134
Date of REC Opinion
10 Apr 2018
REC opinion
Further Information Favourable Opinion