Osteoporosis Musculoskeletal Diseases Osteoporosis without pathological fracture
Conditions
Interventions
Patients randomised to:
1. Treatment with once-monthly ibandronic acid and feedback on the change in their bone turnover marker
2. Treatment with once-monthly ibandronic acid and a patient support pro
Sponsors
Roche Products Ltd (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with postmenopausal osteoporosis diagnosed according to the clinical judgment 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 bisphosphonate 2. Patients who have had a fracture(s) in the past 6 months 3. Patients who have been on hormone replacement therapy (HRT) in the past 6 months 4. Patients who are unlikely to complete the entire 6-month study period due to significant medical condition 5. Patients with an inability to stand or sit upright for at least 60 minutes 6. Patients with abnormalities of the oesophagus that delay oesophageal emptying, such as achalasia and stricture 7. Patients with hypersensitivity to bisphosphonates 8. Administration of any investigational drug within 30 days preceding the first dose of the study drug 9. Patients with galactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess persistence on treatment (time on therapy) of once-monthly ibandronic acid when patients are randomised to either ibandronic acid with patient support programme (PSP) or once-monthly ibandronic acid with bone turnover marker monitoring (BM). | — |
Secondary
| Measure | Time frame |
|---|---|
| To ascertain reasons for discontinuation from treatment. | — |
Countries
United Kingdom
Outcome results
None listed