The Incidence and Risk factors for Hypocalcaemia Among Osteoporosis Patients Receiving Romosozumab or Other Antiresorptive Therapy in Japan -- A Retrospective Cohort Study Within the Medical Information Database Network (MID-NET)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  EVENITY
• Study drug International non-proprietary name (INN) or common name:
  ROMOSOZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (M05BX06) romosozumab

  romosozumab
• Additional medical condition(s):
  Hypocalcaemia

Population studied

• Short description of the study population:
  The target populations will include osteoporosis patients treated with romosozumab or active comparators, namely antiresorptive therapies known to increase the risk of hypocalcaemia (denosumab, bisphosphonates, and selective estrogen receptor modulators [SERMs]).
• Age groups:
  Adults (18 to < 65 years)

  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
• Special population of interest, other:
  4,200 romosozumab users; 30,069 active comparator users
• Estimated number of subjects:
  34269

Study design details

• Study design:
  A retrospective cohort study within the Medical Information Database Network
• Main study objective:
  The primary objective is to evaluate the risk of hypocalcaemia in participants receiving romosozumab relative to those receiving other antiresorptive treatments, broken down by the presence of potential risk factors for hypocalcaemia including renal impairment and others at follow-up initiation.