Post Menopausal Osteoporosis Clinical Trial
— PILOTEOfficial 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
NCT number | NCT02347865 |
Other study ID # | 20130240 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 16, 2015 |
Est. completion date | September 27, 2018 |
Verified date | November 2022 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
France | Amgen | Paris |
Lead Sponsor | Collaborator |
---|---|
Amgen |
France,
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 |
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