Postmenopausal Osteoporosis Musculoskeletal Diseases Osteoporosis without pathological fracture
Conditions
Interventions
The once-monthly single tablet of ibandronate 150 mg (study drug) will be provided for those patients randomised to group A together with a patient support programme, and the comparator alendronate 70
Sponsors
Roche Products Limited (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with postmenopausal osteoporosis diagnosed according to clinical judgement of the treating physician 2. Patients who, in the opinion of the investigator, are able to comply with the protocol requirements and are independent (self-caring) 3. Patients who have signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who were previously exposed to or are currently on a biphosphonate 2. Unlikely to complete the entire 6-month study period due to significant medical condition 3. Inability to stand or sit upright for at least 60 minutes 4. Abnormalities of the oesophagus that delay oesophageal emptying, such as achalasia and stricture 5. Hypersensitivity to biphosphonates 6. Administration of any investigational drug within 30 days preceeding the first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistence (time on therapy) of patients receiving once-monthly dosing of ibandronate with patient support programme versus patients receiving once-weekly alendronate. Persistence with therapy will be measured on the basis of the number of months of study drug dispensed to the patient by the pharmacy i.e. prescription refills. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All patients that withdraw from the study must have the reason for discontinuation recorded 2. All adverse events will be reported as part of general safety assessments | — |
Countries
United Kingdom
Outcome results
None listed