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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Persistence and compliance of osteoporosis medications
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DENOSUMAB

  ALENDRONATE SODIUM TRIHYDRATE

  ZOLEDRONATE DISODIUM HYDRATE

  IBANDRONATE SODIUM HYDRATE

  RISEDRONATE SODIUM

  STRONTIUM RANELATE

  ETIDRONATE DISODIUM

  RALOXIFENE

  TERIPARATIDE
• Medical condition to be studied:
  Osteoporosis postmenopausal

Population studied

• Short description of the study population:
  Postmenopausal women in the UK from CPRD.
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  60000

Study design details

• Main study objective:
  To evaluate whether persistence and compliance to osteoporosis therapies in postmenopausal women with osteoporosis has improved by the introduction of new parenteral therapies.
• Outcomes:
  To estimate persistence and refill compliance to osteoporosis therapies (both oral and parenteral) in a real-world setting over 6, 12, 18, 24 month follow-up periods in postmenopausal women. To estimate persistence and refill compliance to osteoporosis therapies (both oral and parenteral) in a real-world setting over 6, 12, 18, 24 month follow-up periods in postmenopausal women who are treatment-naïve and also in those who are non-naïve treated.
• Data analysis plan:
  Analyses supporting the primary and secondary objectives will describe persistence (quantified using Estimated Level of Persistence with Therapy (ELPT)) and compliance (quantified using medication possession ratio (MPR) for oral therapies and medication coverage ratio (MCR) for parenteral therapies) in patients starting and finishing any new osteoporosis therapy during 2010-2015. Outcomes will be assessed for the entire study population and separately, for treatment naïve and non-naïve treated patients with persistence and compliance assessed over 6, 12, 18, 24 months, 3 and 5 years. All summaries of data will be descriptive in nature. Categorical variables (including the primary outcome), the frequency and percentage, with 95% confidence interval, will be presented. Statistics for continuous variables will include the number of subjects, mean, median, standard deviation or standard error, 25th percentile (Q1), 75th percentile (Q3), minimum, and maximum.

Documents

Study results

Study 20161092 ORSR Abstract for CTD EnCePP 27th July 2018 redacted