E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
osteoporosis in postmenopausal women |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031285 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the impact of bone marker feedback (bloodsampling + communication of the results) on adherence to once monthly ibandronate in women with postmenopausal osteoporosis. |
|
E.2.2 | Secondary objectives of the trial |
- 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.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
trial on adherence to treatment |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The final follow-up call will occur 15-30 days after the final visit |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |