Integrated Retrospective Analysis of Metastatic-related and Non metastatic-related Fractures in Studies 20050136, 20050244, and 20050103

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30045
• EU PAS number:
  EUPAS24775
• Study ID:
  30045
• Official title and acronym:
  Integrated Retrospective Analysis of Metastatic-related and Non metastatic-related Fractures in Studies 20050136, 20050244, and 20050103
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Descriptive analysis of on-study metastatic and non-metastatic fractures from studies 20050136, 20050103,and 20050244 in subjects with bone metastases from solid tumors. To describe additional risk factors associated with on-study non-metastatic fractures for subjects with on-study non-metastatic fracture(s) This study will fulfil a postmarketing commitment to the US Food and Drug Administration (FDA) (part of the approval of XGEVA® prior approval supplement which added Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation to Warnings & Precautions section of XGEVA US Prescribing Information).
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 19/06/2018

Actual: 19/06/2018

Study start date

Planned: 01/12/2018

Actual: 07/09/2018

Data analysis start date

Planned: 01/03/2019

Actual: 21/11/2018

Date of final study report

Planned: 01/06/2019

Actual: 08/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

01.02.06 Public Redacted Protocol Ver 1.0 2018-06-19 English

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

20180024