Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
Condition: Post Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Observational

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.
    

Intervention name(s): AMG 162 - Prolia; AMG 162 - Prolia
Intervention type(s): Drug; Drug
Intervention description(s): 500 patients; 250 patients, one year later
Other intervention name(s): denosumab; denosumab
Intervention MeSH terms: Denosumab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        post menopausal women with osteoporosis, treated with Prolia
      
Keywords: osteoporosis post menopausal women