Prolia® persistence in post-menopausal women with osteoporosis, over 70 years, at increased risk of fracture, treated in routine clinical practice in Bulgaria

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Persistence to treatment in women at increased risk of fracture
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  National retrospective and prospective observational study based on clinical data of PMO women at increased risk of fracture receiving treatment with Prolia® for osteoporosis in routine clinical practice in Bulgaria.

Study drug and medical condition

• Name of medicine:
  PROLIA
• Medical condition to be studied:
  Osteoporosis postmenopausal

Population studied

• Short description of the study population:
  Postmenopausal women > 70 years at increased risk of fracture, with/without previous fracture in real life clinical practice referred by orthopedic, neurology or other clinical outpatients and hospital settings to endocrinology and rheumatology centers to be diagnosed with osteoporosis and treated with Prolia® as per specialist’s decision will be included in the study.; Inclusion criteria:; - Women with osteoporosis >70 years old, referred to endocrinologists or rheumatologists by orthopedic, neurology or other clinics/outpatient practices – to be diagnosed with Dual energy X-ray absorptiometry (DXA) and treated with Prolia®; - The patient - meeting FRAX criteria for high risk: either ≥ 3% risk for hip fracture or ≥20% for major osteoporotic fracture; - The patient has received at least 1 Prolia® injection prior to approval of the study by Bulgarian Regulatory Agency and Bulgarian Central Ethics Commission. The date of the approval comes into force when Amgen has been handed the written decisions.; Exclusion criteria:; - Participation in clinical or device trials in the last 6 months; - Patient is currently participating or has participated in Prolia® clinical trials; - Patient is on other anti-osteoporosis medication at the time of enrolment (e.g. oral/i.v. bisphosphonates, or anabolics). Vitamin D and Calcium supplementation are not considered as osteoporosis medication and therefore are permitted.
• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Osteoporosis patients
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  To estimate persistence with Prolia® in Prolia treated post-menopausal women with osteoporosis, aged >70 years, at increased risk of fracture, at 12, 18 and 24 months in real life clinical practice in Bulgaria.
• Outcomes:
  Persistence to Prolia®, time to non-persistence/discontinuation, -Age, age at menopause, prior fragility fracture, prior PMO therapy, history of treatment discontinuation of osteoporosis therapy, FRAX at baseline, -Number of injections received per patient at the end of the study and after 12, 18 and 24 months -Changes from baseline in BMD T-score
• Data analysis plan:
  Baseline characteristics will be summarized using descriptive statistics. Counts and percentages will be provided for categorical outcomes. Continuous outcomes will be summarized by the number of non-missing values, mean, standard deviation, median, lower and upper quartiles and minimum and maximum values.

Documents

Study results

EUPAS19156-37684