The use, safety, and effectiveness of Prolia in clinical practice among Chinese women with post-menopausal osteoporosis ─ Taiwan and Hong Kong (20180325)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37411
• EU PAS number:
  EUPAS26372
• Study ID:
  37411
• Official title and acronym:
  The use, safety, and effectiveness of Prolia in clinical practice among Chinese women with post-menopausal osteoporosis ─ Taiwan and Hong Kong (20180325)
• DARWIN EU® study:
  No
• Study countries:
  Hong Kong

  Taiwan
• Study description:
  Among Chinese women being treated in clinical practice forpost-menopausal osteoporosis, the objectives are to describe the use of denosumab, characterize the safety of denosumab, and to evaluate the effectiveness of denosumab for the reduction of clinical osteoporotic fractures.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

National Cheng Kung University, Tainan School of pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, The University of Hong Kong, Hong Kong Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine

Study timelines

Date when funding contract was signed

Planned: 01/08/2018

Actual: 01/08/2018

Study start date

Planned: 21/01/2019

Actual: 21/01/2019

Data analysis start date

Planned: 21/01/2019

Actual: 21/01/2019

Date of final study report

Planned: 01/08/2020

Actual: 28/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20180325_01.02.06 Public Redacted Protocol Ver 1.0 2019-01-02 English

Regulatory

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