UCB Study OP0009 RWE/NIS study
Research type
Research Study
Full title
Patient Characteristics and Utilization Patterns of Romosozumab in Routine Clinical Practice: A European, Multi-Country, Non-interventional Study (PRIME)
IRAS ID
348064
Contact name
Richard Keen
Contact email
Sponsor organisation
UCB Biopharma SRL
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
Romosozumab (EVENITY) has been approved for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture, and Romosozumab treatment is recommended to be followed with an antiresorptive. National clinical guidelines for the identification of patients with severe osteoporosis, patient eligibility to receive Romosozumab treatment, and payer reimbursement criteria for Romosozumab treatment differ significantly among European countries. Therefore, understanding the characteristics of patients receiving Romosozumab treatment, their persistence to the 12-dose course of Romosozumab treatment, and transition to antiresorptive medications in actual clinical practice is of great interest from medical, healthcare provider, and market access points of view.
The overall aim of this multi-country, non-interventional study is to collect real-world evidence (RWE) on the characteristics of patients receiving Romosozumab treatment and their treatment patterns in actual clinical practice.
The primary objectives are to 1) describe patient-related, site-related, and country-related characteristics of patients at the start of Romosozumab treatment, 2) evaluate persistence of patients to Romosozumab treatment, and 3) describe treatment pattern and transition to antiresorptives after Romosozumab treatment.The secondary objectives are to 1) identify predictors of Romosozumab persistence among patient/site/country characteristics, 2) assess patient and site characteristics of Romosozumab patients in different countries, and 3) describe the changes in population characteristics of Romosozumab patients over time (to assess channeling bias).
The exploratory objectives are to 1) describe patient/site/country characteristics of Romosozumab patients in predefined study subgroups and 2) evaluate changes in bone health measures following the start of Romosozumab treatment in real-world settings.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
24/YH/0280
Date of REC Opinion
13 May 2025
REC opinion
Further Information Favourable Opinion