Clinical trial NCT02347865: Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Menopausal Osteoporosis
Keywords: osteoporosis post menopausal women
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 777
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: post menopausal women with osteoporosis, treated with Prolia

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: patient occurence of persistence (persistence is defined in the outcome description) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: patient occurence of persistence (persistence is defined in the outcome description) at 24 months and time to non-persistence at 24 months
timeFrame: 24 months
measure: describe the use of Prolia in routine clinical practice during approximately 30 months from the first injection
timeFrame: 30 months from first injection
measure: patient occurence of Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs) as collected in routine clinical practice
timeFrame: 30 months or early termination
measure: Occurrence of patient reported osteoporosis related vertebral and non vertebral fractures reported during the study
timeFrame: 30 months or early termination
Other outcomes:
Locations:
city: Paris
country: France
facility: Amgen
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: