E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hPrevention of glucocorticoid-induced osteoporosis in postmenopausal women diagnosing any inflammatory rheumatoid disease polymyalgia rheumatica |
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MedDRA Classification |
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 investigate the efficacy and safety of once monthly ibandronate (150 mg po) plus vitamin D and calcium supplementation in the prevention of glucocorticoid-induced osteoporosis in postmenopausal women compared to oral placebo plus vitamin D and calcium supplementation |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Postmenopausal women 2. ≥ 1 years from menopause 3.Age 50-85 4.Having diagnosis of any inflammatory rheumatoid disease including polymyalgia rheumatica 5.Receiving treatment with 5-15 mg/day of prednisone 6.Mean lumbar spine (L1-L4) BMD ≥ -2.0 7.Treatment for rheumatic disease stable for 3 months before entering the study 8.Presumably 5-15 mg/day prednisone treatment for at least one year
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E.4 | Principal exclusion criteria |
1.Clinical osteoporotic fractures 2.Femoral neck BMD < -2.0 3.Conditions that may interfere with the evaluation of spinal or hip osteoporosis by DXA such as 2 or more vertebral fractures L1-L4. 4.Hypersensitivity to any component of ibandronate 5.Contraindication to calcium or vitamin D therapy 6.nability to stand or sit in an upright position for at least 60 minutes 7.Inability to swallow a tablet whole 8.Serum Total Ca2+ > 2.6 or < 2.0 mmol/l 9.Renal impairment defined by creatinine clearance <30 ml/min (calculated) 10.Administration of any investigational drug within 30 days preceding the first dose of study drug 11.Previous treatment with an oral bisphosphonate within the last 6 months, more than 1 month of treatment within the last year, more than 3 months of treatment within the last two years 12.Previous treatment with an IV bisphosphonate at any time 13.Treatment with PTH in the past 2 years 14.Treatment with other drugs affecting bone metabolism within the last 6 months e.g., estrogens (except for vaginal administration), progestins, selective estrogen receptor modulators (SERMs), calcineurin inhibitors, anabolic steroids/androgens, active vitamin D analogs/metabolites (alfacalcidol, calcitriol), calcitonin 15.Active disease/disorder known to influence bone metabolism, such as untreated or uncontrolled hyperthyroidism, hyperparathyroidism, osteomalacia, liver disease, chronic alcoholism or severe malabsorption syndrome 16.Malignant disease (except resected basal cell cancer and treated cervic carcinoma in situ) 17.untreated celiac disease 18.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, and - 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) |
1. Change (%) from baseline in mean lumbar spine (L1-L4) BMD at 12 months |
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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 | Information not present in EudraCT |
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 | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Calcium 1000mg and D vitamin 800IU |
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E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
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
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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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |