E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Long term study in women with postmenopausal osteoporosis. |
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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 study the tolerability and safety (including bone histomorphometry) of long-term treatment with intravenous ibandronate administered as 2 regimens, either 2 mg every 2 months or 3 mg every 3 months. |
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E.2.2 | Secondary objectives of the trial |
In addition, the study will assess effect of these regimens on lumbar spine and total hip BMD and markers of bone turnover. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Patients who completed the 2 year treatment period in study BM16550 and who had a 75% or more compliance to the IV regimen during the last year of the study; i.e., missed no more than one IV injection during the second year of study BM16550; • Patients with at least 2 evaluable (L2-L4) vertebrae present on the 2 year lumbar spine BMD scan in study BM165501; • Patients must be ambulatory at the beginning of the trial. It must not be anticipated that the patient becomes hospitalized, immobilized, or bedridden during the course of the trial; • Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration; • Patients who have provided written informed consent to participate in the study. |
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E.4 | Principal exclusion criteria |
• Patients who completed the 2 year treatment period in study BM16550 more than 3 months prior to the planned baseline visit for study MA17904; • Severe renal failure (2calculated GFR < 30 ml/min.); • Malignant disease diagnosed since inclusion into study BM16550 (except successfully resected basal cell cancer); • Disease/disorder known to influence bone metabolism: Chronic gastrointestinal or liver disease, chronic alcoholism, severe malabsorption syndrome, primary hyperparathyroidism (patients with surgically treated hyperparathyroidism with documented normal serum calcium and PTH will be eligible for enrollment), Paget's disease of bone, histologically documented osteomalacia, or documented active thyroid disease without treatment; • Administration of any investigational drug other than ibandronate within 30 days preceding the first dose of the study drug; • Treatment with drugs affecting bone metabolism since the inclusion of the patient into study BM16550, including: o Fluoride (dose greater than 10 mg/day); o Strontium; o PTH or similar anabolic agent; o Systemic hormones (e.g. estrogens3, progestins, SERMs, anabolic steroids, active Vitamin D analogs/metabolites, calcitonin); o Calcineurin inhibitors [e.g. cyclosporine, tacrolimus]4 or methotrexate; o Treatment with any bisphosphonate other than ibandronate. • Treatment with chronic systemic corticosteroid5 at doses affecting bone metabolism within the last 6 months.
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the long-term safety and tolerability of intravenous ibandronate therapy. The safety of long-term IV ibandronate treatment will be assessed by means of adverse events, laboratory tests and bone histomorphometry. Secondary endpoints: To investigate lumbar spine and total hip BMD changes after long-term treatment with IV ibandronate and to investigate trough and peak serum CTX suppression at steady state. The primary efficacy variable is the relative change (%) from baseline at 36 months in mean lumbar spine (L2-L4) BMD.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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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The final follow-up will occur 15 days after treatment completion. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |