Treatment of postmenopausal osteoporosis to reduce the risk of hip and vertebral fractures [Osteoporotic fracture] MedDRA version: 7.0 Level: PT Classification code 10031290
Conditions
Interventions
Trade Name: Protelos
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: Strontium Ranelate
CAS Number: 7440-24-6
Current Sponsor code: S12911-2
Concentration unit: g gram(s)
Concen
Sponsors
Servier s.r.o
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The main inclusion criteria will be: (1) female adults at least 50 years of age, (2) postmenopausal for at least 5 years, (3) newly diagnosed patients, not treated with any antiosteoporotic drug for certain period before the inclusion, (4) with established osteoporosis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The main exclusion criteria will be: (1) patient experienced hip fracture at last 6 months before M0 visit, (2) patient treated with systemic corticosteroids within the last 6 months before the inclusion and other drugs with influence on the bone metabolism, (3) patient suffering from disease known to influence bone metabolism, (4) patient with previous history of venous trombembolism, (5) history of malignant disease in the prior 5 years, (6) patient suffering from severe renal impairment, (7) patient with phenylketonuria, (8) patient receiving experimental medication other than that recommended in the present study, or having participated to another clinical trial during the previous 3 months, (9) treatment with oral tetracycline or quinolone antibiotics, (10) hypersensitivity to the active substance or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to evaluate the adherence to Protelos2g: the compliance with the treatment (the percentage of doses taken) and the persistence on the treatment (the number of days until discontinuation, the evaluation of proportion of patients continuing treatment during treatment period, the treatment satisfaction questioning), the improvement of the quality of life including back pain (assessed by the visual analogue scale questioning) in patients suffering from postmenopausal osteoporosis taking Protelos2g.;Secondary Objective: The secondary aim is to demonstrate the acceptability of Protelos2g (adverse drug reactions, BMI, blood pressure and heart rate, patient's questions using VAS), the clinical efficacy (relative change in lumbar spine and total hip BMD from baseline assessed by dual energy X-ray Absorptiometry, DXA).;Primary end point(s): The primary end points are: (1) The compliance with the treatment, (2) The evaluation of treatment persistence, (3) The quality of life assessment. | — |
Countries
Czech Republic
Outcome results
None listed