Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(M05BA) Bisphosphonates
Bisphosphonates

Medical condition to be studied

Chronic kidney disease
Osteoporosis
Osteoporotic fracture
Population studied

Short description of the study population

Participants aged 40 years or older, with chronic kidney disease (CKD) stage 3B or above (eGFR<45ml/min/1.73m2).

Age groups

Adults (18 to < 46 years)
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

204528
Study design details

Main study objective

To study the association between oral bisphosphonate use and 1.fracture risk (ie benefits) and 2.known adverse events amongst patients with CKD.

Outcomes

1. CKD progression, 2 osteoporotic (all but face/skull/fingers/toes) fracture/s. 3.acute kidney injury, hospitalization for hypocalcemia/hypophosphataemia, or upper gastro-intestinal events, and 4: annualized hip BMD % change. CKD progression as based on eGFR changes over time.

Data analysis plan

BP use will be introduced as a time-varying exposure. Cox regressionstratified by propensity matched sets will be used to estimate the association between BP use and the study outcomes(WP1/2/3). Linear regression models will be fitted to study the association between BP use and hip BMD in CKD patients(WP4).A more detailed analysis plan is available in the enclosed study protocol.