Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(M05BX04) denosumab

Medical condition to be studied

Osteoporosis
Population studied

Short description of the study population

Postmenopausal women receiving treatment for osteoporosis.

Age groups

Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

2000000
Study design details

Main study objective

To assess the treatment patterns and the impact of osteoporosis medication on fracture incidence in France

Outcomes

To assess the change in fracture risk after treatment initiation among post-menopausal women receiving osteoporosis treatment, overall and stratified by type treatment and type of fracture, • To describe osteoporosis treatment patterns among post-menopausal women receiving osteoporosis treatment, • To describe characteristics of post-menopausal women receiving osteoporosis treatment, • To assess the change in fracture risk after treatment discontinuation among post-menopausal women receiving osteoporosis treatment, overall and stratified by type treatment and type of fracture

Data analysis plan

• Flow chart for population selection • Description of baseline characteristics • Description of drug use by duration of treatment, discontinuation, switching and adherence • Description of the fracture outcome as the unadjusted risk and rate • Fracture incidence rate assessed during three periods: 1. Early treatment period (first 3 months post-index, which assumes a delay in fracture reduction following treatment initiation) 2. Treatment exposure period (subsequent time on treatment after the first 3-months post-index, until end of follow up or treatment discontinuation) 3. Post-discontinuation period (period of time with no treatment after treatment discontinuation) • Fracture incidence rates will be compared between the early treatment period and the treatment exposure period using incidence rate ratios using an own-control analysis • Fracture incidence rate in the post-discontinuation period will be compared with the early treatment period and treatment exposure period
Documents
Study publications
Bosco-Lévy P, O’Kelly J, Briot K, Mehsen-Cetre N, Fabre A, Lassalle R, et al. E…