NCT02347865

Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 777 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France

Detailed description

This is a multicenter, observational and non-interventional study in PMO patients who receive Prolia® (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 enroll approximately 500 patients who will be followed for approximately 30 months from the first injection. 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, 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. Around 2000 specialists in rheumatology and 9000 general practitioners will be randomly selected from a list of rheumatologists whether in hospital or private practice nationwide and a list of general practitioners managing patients with osteoporosis. In all, 300 physicians initially interested to participate are expected, from which about 180 physicians will be qualified to participate. One-hundred and ten physicians will be initiated. There are no procedures or changes to the routine clinical management of patients participating in the study. Baseline characteristics will be described for patients enrolling in both waves 1 and 2. Patients enrolling in wave 1 will be followed for approximately 30 months from the date of first injection in the study. It is anticipated that patients will return to the site. Clinical information obtained for routine clinical practice will be recorded where available, including Prolia administration, previous and current therapies, medical history (including fracture), ADRs, SADRs and co-morbidities.The study is descriptive in nature, and no formal hypothesis will be tested. In general, data summaries will be presented by wave and by subgroups of interest.

Conditions

• Post Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	AMG 162 - Prolia	500 patients
DRUG	AMG 162 - Prolia	250 patients, one year later

Timeline

• Start date: 2015-06-16
• Primary completion: 2017-10-26
• Completion: 2018-09-27
• First posted: 2015-01-27
• Last updated: 2022-11-14

Locations

1 site across 1 country: France