Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and its use in Routine Clinical Practice (20130240)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29204
• EU PAS number:
  EUPAS24541
• Study ID:
  29204
• Official title and acronym:
  Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and its use in Routine Clinical Practice (20130240)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This is a multicenter, observational and non-interventional study in PMO patients who receiveProlia® (60 mg subcutaneous SC) in France. Patients in the study will be enrolled in 2 waves,each targeting specific aspects of the overall study objectives. The first wave will enrol approximately 500 patients who will be followed for approximately 30 months from the date of enrollment. Patients enrolled in this wave will provide descriptive data on persistence to Prolia® as well as a description of the characteristics of patients being prescribed Prolia®, information regarding Prolia® prescription and administration, and procedures pertaining to Prolia® and safety. The second wave will enroll approximately 250 patients and will only provide a cross-sectional description of the characteristics of patients being prescribed Prolia®
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 94 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned: 16/06/2015

Actual: 16/06/2015

Study start date

Planned: 16/06/2015

Actual: 16/06/2015

Data analysis start date

Planned: 21/06/2016

Actual: 27/09/2018

Date of interim report, if expected

Planned: 01/12/2017

Actual: 01/11/2016

Date of final study report

Planned: 26/02/2019

Actual: 22/02/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

EUPAS24541-26946

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

NCT02347865