Prolia® persistence in post-menopausal women with osteoporosis, over 70 years, at increased risk of fracture, treated in routine clinical practice in Bulgaria

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37686
• EU PAS number:
  EUPAS19156
• Study ID:
  37686
• Official title and acronym:
  Prolia® persistence in post-menopausal women with osteoporosis, over 70 years, at increased risk of fracture, treated in routine clinical practice in Bulgaria
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria
• Study description:
  The purpose of this study is to estimate persistence with Prolia® in Prolia® treated at increased risk of fracture postmenopausal women, aged >70 years, at 12, 18 and 24 months in real life clinical practice in Bulgaria. Objective is to estimate the proportion of patient at increased risk of fracture on Prolia® treatment for 2 years. Demographic and clinical characteristics in -increased risk of fracture women >70 years with osteoporosis and treated with Prolia® will be described.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 14 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 22/03/2017

Actual: 22/03/2017

Study start date

Planned: 14/07/2017

Actual: 11/07/2017

Data analysis start date

Planned: 30/11/2019

Actual: 07/11/2019

Date of final study report

Planned: 20/10/2020

Actual: 20/10/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol Summary

Regulatory

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