Forteo/Forsteo post-approval osteosarcoma surveillance study

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:
  Case-finding surveillance study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-finding surveillance study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TERIPARATIDE
• Medical condition to be studied:
  Osteosarcoma

Population studied

• Short description of the study population:
  Men and women aged 40 years or older at the time of diagnosis and had histological confirmation of osteosarcoma or one of five other tumour types with a primary bone site were identified through the Scandinavian Sarcoma Group (SSG) registry and the Finnish and Swedish National Cancer Registries.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Osteosarcoma patients
• Estimated number of subjects:
  112

Study design details

• Main study objective:
  The primary objective was to identify newly diagnosed cases of osteosarcoma among men and women aged 40 years or older in selected countries and identify incident osteosarcoma cases with a history of teriparatide treatment. The secondary objective was to collectadditional patient information and data related to other risk factors for osteosarcoma.
• Outcomes:
  Osteosarcoma
• Data analysis plan:
  The analysis compared the observed number of patients with osteosarcoma(OS) with a possible or confirmed exposure to teriparatide to the number of exposed OS cases expected to be identified by cancer registries. The number of patients treated with teriparatide expected tobe diagnosed with OS was calculated using the estimated size of the exposed population and background rate for OS in the Nordic countries (i.e. assuming no association between drug exposure and disease). The incidence rate for OS was generated from population estimates foreach country, as well as published population-based OS incidence. Population estimates for adults aged 40+ yrs were based on national statistics data for each country. Because this population grew from approximately 12 million in 2004 to 13.24 million in 2013, the population at the approximate midpoint of the study (2008), 12.6 million people aged 40+ yrs, was used for relevant estimates.