Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
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

Medical condition to be studied

Osteoporosis
Population studied

Short description of the study population

Participants who initiated Romosozumab in Guangdong province hospitals where Romosozumab is available through special medical zone policy since October 2024.

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

300
Study design details

Study design

This is a retrospective cohort study of participants who initiated Romosozumab in Guangdong, China.

Main study objective

The main objectives of this study are:
• To describe characteristics of participants initiating Romosozumab and its utilization.
• To describe change of available bone mineral density, bone turnover markers, and participant reported pain scores.
• To characterize the safety profile of Romosozumab.

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.
• Changes in bone mineral density (BMD) from baseline at the lumbar spine, total hip and femur neck at 6 and 12 months.
• Changes in bone resorption and formation markers (e.g., C-terminal Telopeptide [CTX], Procollagen Type 1 N-terminal Propetied [P1NP]) at 1, 3, 6 and 12 months.
• Changes in pain score at available time points.
• Number of recorded adverse events and serious adverse events since the first dose injection in the data source.

Data analysis plan

Descriptive analysis will describe the number of Romosozumab participants by participant history, disease characteristics, and the duration of Romosozumab use.

The number of recorded safety events will be estimated during study follow-up. For BMD analysis, percentage change from baseline at 6 and 12 months will be calculated. A minimum dosage is required for BMD analysis, 5 doses for the 6-month analysis or 10 doses for the 12-month analysis. Compared to baseline levels, the values of bone turnover biomarkers will be described at 1, 3, 6 and 12 months.

Pain score will not be available in all study sites and change from baseline will be described at available timepoints. Pain score will also be analyzed according to whether a participant had recent orthopedic surgery.

A stratified analysis of effectiveness outcomes will be conducted by types of osteoporosis medication used before Romosozumab initiation and by study sites.