Persistence and compliance to anti-osteoporosis medications in the United Kingdom using the Clinical Practice Research Datalink (CPRD) (20160192)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25344
• EU PAS number:
  EUPAS18402
• Study ID:
  25344
• Official title and acronym:
  Persistence and compliance to anti-osteoporosis medications in the United Kingdom using the Clinical Practice Research Datalink (CPRD) (20160192)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  We aim to evaluate persistence and compliance to osteoporosis therapies in post-menopausal women (including premature or surgery-induced menopause) who receive at least one prescription for any licensed medication between 2010 and 2015. Patients with history of cancer, metabolic bone disease before or on the index date, less than 12 months of medical history before the index date and less than six months of medical records after the index date 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. Secondary objectives will be to estimate persistence and refill compliance over the same time periods in postmenopausal women who are treatment-naïve and non-naïve 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).
• Study status:
  Finalised

Research institution and networks

Institutions

Amgen

United States

Clinical Practice Research Datalink (CPRD)

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 20/05/2016

Actual: 20/05/2016

Study start date

Planned: 01/05/2017

Actual: 01/05/2017

Data analysis start date

Planned: 01/06/2017

Actual: 01/06/2017

Date of final study report

Planned: 30/06/2018

Actual: 28/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20160192 CPRD study protocol 29th March 2017 (redacted)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable