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

Post Menopausal Osteoporosis Clinical Trial

— PILOTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347865
• Other study ID #: 20130240
• Status: Completed
• Start date: June 16, 2015
• Est. completion date: September 27, 2018

Study information

• Verified date: November 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 777
• Est. completion date: September 27, 2018
• Est. primary completion date: October 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 95 Years

Eligibility

Inclusion Criteria:

• post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks

• received their first prescription of Prolia in the last 4 weeks

• patient has provided informed consent before enrolling in the study

Exclusion Criteria:

• patients participating in ongoing or previous Denosumab clinical trials

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post Menopausal Osteoporosis

Intervention

Drug:
• AMG 162 - Prolia
500 patients
• AMG 162 - Prolia
250 patients, one year later

Locations

Country	Name	City	State
France	Amgen	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient occurence of persistence (persistence is defined in the outcome description) at 12 months	To evaluate the persistence with Prolia at 12 months in post menopausal women with osteoporosis (PMO) in France. To evaluate the persistence with Prolia at 24 months in PMO women in France. Patients will be defined as persistent with Prolia at 12 months if the patient receives at least 2 injections and the second injection at 6 months is no later than 6 months + 8 weeks (or 239 days) from the baseline injection	12 months
Secondary	patient occurence of persistence (persistence is defined in the outcome description) at 24 months and time to non-persistence at 24 months	To evaluate the persistence with Prolia at 24 months in PMO women in France. Patients will be defined as persistent with Prolia at 24 months if the patient receives at least 4 injections (including the baseline) and the time between any 2 injections is not more than 6 months + 8 weeks (or 239 days)	24 months
Secondary	describe the use of Prolia in routine clinical practice during approximately 30 months from the first injection	to describe the occurence of patients referred to another physician for follow up on prolia treatment, the number of injections received by the patient, the occurence of a patient receiving the first, second, third, fourth and fifth injections, the number of times a patient received Prolia injection by the prescriber and the number of times a patient received a Prolia injection outside the prescriber's office by nurse or other healthcare provider	30 months from first injection
Secondary	patient occurence of Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs) as collected in routine clinical practice	to describe the patient occurence of ADRs and SADRs as collected in routine clinical practice	30 months or early termination
Secondary	Occurrence of patient reported osteoporosis related vertebral and non vertebral fractures reported during the study	Patient occurence of osteoporosis related vertebral and non vertebral fractures during the study. Osteoporosis related fractures are defined as all fractures excluding skull, facial bones, mandible, metacarpus, finger phalanges, toe phalanges and cervical vertebrae and not associated with known high trauma severity or pathological fractures.	30 months or early termination

External Links

•   AmgenTrials clinical trials website