OPERe
Osteoporosis Egyptian Registry
Project Managers
-
Prof. Naglaa Gadallah
Ain Shams University
-
Prof. Hesham Hamoud
Al Azhar University
-
Prof. Ahmad Emera
Zagazig University
-
Prof. Sherif Refaat
Mansoura University
Objectives
-
General Objective
Concerning the initial treatment of osteoporosis in daily practice this project proposes to describe the Egyptian daily clinical practice reality, delayed diagnosis and use/abuse of the management recommendations.
-
Specific Objectives
Primary objectives
in patients diagnosed with OP , the time between the diagnosis and the initiation of therapy with anti-osteoporotic medications, to assess the compliance with the management recommendations of the initial phase of clinical management to assess the frequency of achievement of the 12 month target.
-
Secondary objectives
-
Early diagnosis and start of anti-osteoporotic medications.
-
To estimate the incidence and prevalence of fragile fracture among Egyptian populations.
-
To estimate the incidence and prevalence of osteopenia among Egyptian populations.
-
To estimate the incidence and prevalence of osteoporosis arthritis among Egyptians.
-
To estimate the average time between diagnosis and the first dosage of treatment.
-
To estimate the average time between visits.
-
To estimate the frequency of patients who start the drug and failed to achieve remission.
-
To evaluate the frequency of adverse events to anti-osteoporotic medications.
Study design
Mixed cohort study. Prospective Study Retrospective Study
Recruitment centers
All rheumatology departments among the Egyptian universities, in addition to some of the potential rheumatology private clinics will have a unique username and password to login and add his last recruitment patients: Consecutive patients. Recruitment 18 months. Minimum 12 month follow-up (First patient assessed: 30 months) study.
Inclusion Criteria: Patients diagnosed with OP performed by the rheumatologist who initiate initial treatment with anti-osteoporotic medications.
Exclusion criteria:
-
Patients not able or refusing to provide informed consent.
Factors of interest (exposure variables)
-
Demographic variable
-
Serological subset
-
Clinical settings (outpatient / hospital / center analysis)
Analysis plan
-
Analysis of the primary outcome
Primary outcomes will be estimated as a mean therapeutic delay and as a probability (risk) of achievement of the target / or adherence to recommendations and 95% confidence intervals.
-
Analysis of secondary outcomes
Secondary outcomes will be estimated in a similar way to primary ones.
-
Explorative analysis
The influence of demographic, clinical (serological), therapeutic factors (association with anti-osteoporotic medications), organizational (setting), pathway (time to referral, to diagnosis ,to treatment) on the variables of longitudinal outcome (target achievement, treatment survival, adverse events, anti-osteoporotic medications switch) will be explored using regression models appropriate to type of outcome variable.