E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031282 |
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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 (using serum CTX and communication of the results) on adherence to once monthly ibandronate in women with postmenopausal osteoporosis supported by PRP (patient relationship program) |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the satisfaction of treatment with monthly ibandronate for each study arm as well as the whole study population including analyses of different patient categories based on the baseline variables (age, previous osteoporosis treatment if any); • To evaluate patient satisfaction with regimen (drug treatment and physician handling); • To evaluate patient satisfaction with a method of assessment through biomarker quantification; • To evaluate physician satisfaction with a method of assessment through biomarker quantification; • To evaluate the effect of monthly ibandronate on suppression of bone turnover markers; • To evaluate the impact of adherence to monthly ibandronate on bonemarker response; • To assess the safety of monthly ibandronate; • To evaluate the impact of PRP on adherence to monthly ibandronate intake |
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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, with documented osteoporosis as determined by the treating physician (menopausa is defined by having amenorrhea for at least one year prior to study entry OR by having previous ovariectomy); • Patients who are either naive 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 |
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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/hypercalcemia or other disturbances of bone and mineral metabolism; • Antiresorptive medication within the last 6 months; • Treatment with other drugs affecting bone metabolism; • 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; • Patients are not excluded because of previous or active gastrointestinal disease, except as outlined above (eg. symptoms of dyspepsia controlled by daily medication or prior history of non-recurrent peptic ulcer disease are not considered exclusionary) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of Adherence For the primary end point patients are defined as having more than 83% adherence to treatment if they took 5 of the 6 monthly ibandronate tablets within the -1 to +21 days of their osteoporosis treatment date each month. Patient adherence will be assessed by maintaining records of “drug dispensed” and “drug returned” on the CRF and patient self-report at visit 2 and final visit. A drug dispensing log will be maintained by the investigator. Patients will be instructed at the baseline visit and at visit 2 to save and return unused or partially used medication packages on visit 2 and final study visit respectively. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 |
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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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |