osteoporosis in postmenopausal women
Conditions
Interventions
Trade Name: Bonviva 150 mg film-coated tablets
Product Name: Bonviva 150 mg film-coated tablets
Product Code: Ro 200-5450
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ibandronic acid
C
Sponsors
N.V. Roche S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Ambulatory post-menopausal women aged 55-85 years eligible for bisphosphonate treatment or with documented osteoporosis as determined by the treating physician in accordance with local practice; - Patients who are either naïve to bisphosphonates or lapsed bisphosphonate users (last bisphosphonate intake > 6 months ago); - Patients who, in the opinion of the investigator, are able to understand and complete the questionnaires, are willing and able to comply with the protocol requirements; - Patients who have signed the informed consent. 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: - Hypersensitivity to bisphosphonates; - Inability to stand or sit in an upright position for at least 60 minutes; - Inability to swallow a tablet whole; - Contraindications to calcium or vitamin D therapy; - Administration of any investigational drug within 30 days preceding the first dose of the study drug; - Uncorrected hypocalcemia or other disturbances of bone and mineral metabolism; - Administration of antiresorptive medication within the last 6 months (bisphosphonates, SERMs, calcitonin and hormone replacement therapy); - Active disease/ disorder known to influence bone metabolism; eg. liver disease, chronic alcoholism, severe malabsorption syndrome, documented active thyroid disease without treatment; - Renal impairment (creatinine clearance <30 mL/min); - History of major upper GI disease defined by: - Significant upper GI bleeding within the last year requiring hospitalization or transfusion; - Recurrent peptic ulcer disease documented by radiographic or endoscopic means; - Dyspepsia or gastroesophageal reflux that is uncontrolled by medication; - Abnormalities of the esophagus that delay esophageal emptying, such as stricture, achalasia , or dysmotility; - Active gastric/duodenal ulcers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of bone marker feedback (bloodsampling + communication of the results) on adherence to once monthly ibandronate in women with postmenopausal osteoporosis.;Secondary Objective: - To evaluate the satisfaction of treatment with monthly ibandronate; - To evaluate patient satisfaction with regimen (drug treatment and physician handling); - To evaluate patient satisfaction with a method of assessment through bone marker quantification; - To evaluate physician satisfaction with a method of assessment through bone marker quantification; - To assess the safety of monthly ibandronate. ;Primary end point(s): Comparison of the proportion of patients with adherence to 5 or more administrations of ibandronate within 21 days of the osteoporosis treatment date out of the 6 possible administrations (at least 83 %adherence). The null hypothesis for the primary analysis variable is that the proportion of patients with at least 83% adherence in the bone marker feedback group is not different from that in the no bone marker feedback group. The alternative hypothesis to be tested is that the proportions in the two groups are different. | — |
Countries
Austria, Belgium, Greece, Ireland, Portugal
Outcome results
None listed