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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Post Menopausal Osteoporosis

Intervention / Treatment
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* Drug: AMG 162 - Prolia
* Drug: AMG 162 - Prolia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| wave 1<br>postmenopausal women with osteoporosis treated with Prolia | Drug: AMG 162 - Prolia<br>* 500 patients<br>* Other names: denosumab;|
| wave 2<br>postmenopausal women with osteoporosis treated with Prolia | Drug: AMG 162 - Prolia<br>* 250 patients, one year later<br>* Other names: denosumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis post menopausal women