The aim of this study is to estimate the adherence of postmenopausal women receiving osteoporosis medications in the UK between 2010 and 2015. This will be an update to a previous CPRD study covering 1995-2008 period, by assessment of newer therapies launched after this date, including new non-oral (injectable) therapies. Adherence will be assessed by estimating the numbers and percentages of patients remaining on an osteoporosis medication after 6, 12, 18 and 24 months of start of therapy. The analysis will also evaluate whether adherence is influenced by prior therapy (non-naive treated) or not (treatment-naive). Furthermore, it would try to ascertain the types of patients who end up on specific therapies based on their concomitant diseases or medications, prior fracture history, and prior anti-osteoporosis therapy. This study will evaluate if adherence to anti-osteoporosis oral therapies has been improved with introduction of non-oral therapies (drugs injected once every 6 or 12 months). This study will also evaluate whether patients who have received prior therapies, have multiple co-morbidities, are older or have received multiple concomitant medications would be more likely to receive non-oral therapies (i.e. receive these later in disease management)
We aim to evaluate persistence, time to discontinuation, and refill compliance to osteoporosis therapies in post-menopausal women (including premature or surgery-induced menopause) who received at least one prescription for any licensed medication between 2010 and 2015. Patients with history of cancer or metabolic bone disease and insufficient baseline and follow-up data will be excluded. The primary objective of the study will be to estimate the persistence and refill compliance of osteoporosis therapies (both oral and parenteral) over 6, 12, 18, 24 month follow-up periods. Kaplan-Meier methods will be used to estimate time to discontinuation. Persistence will be estimated as the proportion of patients refilling each subsequent prescription within the grace period every 6 months. Compliance is quantified using the Medication Possession Ratio for oral therapies and medication coverage ratio for parenteral therapies. Secondary objectives will be to estimate adherence measures in postmenopausal women who are treatment-naive and non-naive treated. Outcomes will be assessed for the entire study population and for each of the cohorts of interest. All summaries of the data will be descriptive in nature. We will also present effects of various patient characteristics on the persistence and compliance outcome (e.g. age groups, comorbidities, prior therapies, and concomitant medications).
Estimate persistence to osteoporosis therapies between 2010-2015 (all patients); Estimate refill compliance to osteoporosis therapies between 2010-2105 (across all patients);
Estimate persistence and refill compliance to osteoporosis therapies in treatment-naive patients and non-naive treated patients.
Jason Morley - Chief Investigator - Amgen Ltd
Andrew Taylor - Corresponding Applicant - Amgen Ltd
Alireza Moayyeri - Collaborator - UCB Celltech
Jonathan Bayly - Collaborator - University of Derby
Lisa Hamilton - Collaborator - Amgen Ltd
Maurille Feudjo Tepie - Collaborator - Amgen Ltd