Delayed Denosumab Injections and Fractures Risk Among Subjects with Osteoporosis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35405
• EU PAS number:
  EUPAS32386
• Study ID:
  35405
• Official title and acronym:
  Delayed Denosumab Injections and Fractures Risk Among Subjects with Osteoporosis
• DARWIN EU® study:
  No
• Study countries:
  China

  United Kingdom

  United States
• Study description:
  The overall research question of the proposed study is to examine the fracture risk of delayed denosumab injections among patients who used this medication for long-term osteoporosis management using observational methods in large healthcare databases. The primary exposure delay of subsequent denosumab injections. The primary outcome of interest is composite fracture including all types of fracture. Secondary outcomes include major osteoporotic fracture, vertebral fracture, and hip fracture. The primary analysis strategy is emulating a sequential randomized controlled trials(RCT) comparing the three different strategies (on time, short delay and long delay) using observational data. This study will use an electronic medical record database from general practitioners in the United Kingdom (UK). The analysis will take advantage of naturally occurring variations in the timing of denosumab administration, and examine variation in administration schedule’s impact on fracture risk in routine clinical settings.
• Study status:
  Finalised

Research institutions and networks

Institutions

Brigham and Women's Hospital

National Clinical Research Center for Musculoskeletal Diseases Beijing, China, Xiangya Hospital Changsha, Hunan, China, University of Liverpool Liverpool, UK

Study timelines

Date when funding contract was signed

Actual: 12/03/2019

Study start date

Planned: 07/11/2019

Actual: 14/11/2019

Data analysis start date

Planned: 14/11/2019

Actual: 14/11/2019

Date of final study report

Planned: 31/01/2020

Actual: 18/02/2020

Sources of funding

Other

More details on funding

Xiangya Hospital, National Clinical Research Center for Musculoskeletal Diseases

Study protocol

Initial protocol

a20191006_THIN Proposal-DMAb Delay and Fracture_V1

Updated protocol

a20200521_THIN Proposal-DMAb Delay and Fracture_V3

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable