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

No individual level data collected for the purpose of the study
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

Medical condition to be studied

Osteoporosis
Population studied

Short description of the study population

Participants who received at least 1 injection of Romosozumab between 2 July 2020 and 31 December 2024
in Hong Kong

Age groups

  • In utero
  • Paediatric Population (< 18 years)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

1000
Study design details

Study design

This is a retrospective cohort study of participants who initiated Romosozumab in Hong Kong.

Main study objective

The main objectives of the study are:
• To describe characteristics of participants initiating Romosozumab and use of osteoporosis therapies
• To describe change of bone mineral density among participants initiating Romosozumab

Outcomes

Primary outcomes:
• The following will be described for participants initiating Romosozumab:
o Demographics.
o Clinical characteristics.
o Romosozumab utilization:
 Dose and dosing schedule.
 Total number of injections and duration of treatment.
o Use of osteoporosis therapies after Romosozumab.
• Percentage change of bone mineral density (BMD) from baseline of Romosozumab initiation to follow-up BMD.

Data analysis plan

• Objective 1: Describe characteristics of participants initiating Romosozumab and use of osteoporosis therapies.
o Descriptive analysis will be conducted to describe the disease and medication history, lab values, treatment pattern of Romosozumab users, and use of other osteoporosis therapies after initiating Romosozumab.
• Objective 2: Describe change of bone mineral density among participants initiating Romosozumab.
o For participants in Hong Kong West cluster, their BMD records can be manually extracted from Clinical Management System (CMS) / Electronic Patient Records (EPR) system. The change in baseline BMD (available BMD records up to 90 days before/at Romosozumab initiation) and BMD at 6 and 12 months after initiating Romosozumab will be described among participants with both BMD values at baseline and 6 months, or both BMD values at baseline and 12 months, respectively.