An observational follow-up study for: a phase III randomized, placebo-controlled clinical trial to assess the safety and efficacy of odanacatib (MK-0822) to reduce the risk of fracture in osteoporotic postmenopausal women treated with vitamin D and calcium (Protocol 018) (MK-0822-083)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional observational follow-up study of a randomized clinical trial

Study drug and medical condition

• Medical condition to be studied:
  Osteoporosis

Population studied

• Short description of the study population:
  Postmenopausal women with osteoporosis.
• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  To collect and assess safety information for the double-blinded treatment period ending 5 years post-randomization regarding deaths, SAEs, AEs requiring adjudication, and skin events of clinical interest in participants who were randomized and took at least one dose of blinded study medication, then discontinued from study drug but have not completed follow-up
• Outcomes:
  Number of participants with at least one Tier 1 adverse event
• Data analysis plan:
  No analysis is planned for MK-0822-083 data alone. This study is purely observational. Summary statistics will be provided.