Osteoporosis
Conditions
Keywords
ibandronate, osteoporosis, preference, case-finding, post-menopausal, alendronate
Brief summary
This is a two part study (screening and treatment). The first part (screening) is designed to evaluate the percentage of patients missed in diagnosing osteoporosis by general practitioners (GP's). The second part (treatment) is designed to determine the preference by patients for the once monthly ibandronate or the once weekly alendronate.
Detailed description
A multi-centre, randomised, open-label, cross-over study to evaluate the percentage of false negative osteoporosis diagnoses using the standard case-finding procedure as described by the Dutch Institute for Health Care (CBO) and to determine the preference of adult osteoporosis patients between once monthly dosing of ibandronate (150 mg) and once weekly dosing of alendronate (70 mg).
Interventions
DRUGIbandronate
DRUGAlendronate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women registered with a GP, without a prior history of osteoporosis. According to a case-finding procedure, osteoporosis will be diagnosed or excluded.
Exclusion criteria
* Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. * Inability to stand or sit in the upright position for 60 minutes. * Previous use of bone active agents (e.g. strontium, PTH). * Significant medical condition which may preclude the patient's ability to complete the study. * History of alcohol or drug abuse. * Hypersensitivity to any component of the bisphosphonates alendronate and ibandronate. * Administration of any investigational drug within 30 days preceding the first dose of the study drug. * Serum total calcium \> 10.5 mg/dL or \< 8.0 mg/dL (equivalent to 2.63 mmol/L and 1.99 mmol/L). * Osteoporosis by secondary causes, will be excluded especially when an isolated deformity of the vertebral body is detected during x-ray analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Percentage of patients falsely not diagnosed with osteoporosis using the standard case-finding and additional X-ray procedure in GP practice. Part 2: Patient preference for once monthly ibandronate or once weekly alendronate | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: To assess the safety and tolerance of both ibandronate and alendronate. Part 2: To assess patient preference in reminder methods during once monthly ibandronate regimen: postcard, text message or telephone patient relationship program. | — |
Countries
Netherlands
Outcome results
None listed