E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporosis in postmenopausal women. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
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 |
In postmenopausal women with osteoporosis, to evaluate and compare with placebo the persistence of the effect of oral monthly ibandronate, 100 mg and 150 mg, on percent change from baseline in the biochemical marker of bone resorption, serum carboxyterminal crosslinked telopeptide of Type I collagen (CTx1), during the third month treatment (four weeks post dose compared to one week post dose). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives : In postmenopausal women with osteoporosis: • Persistence of effect of oral monthly ibandronate, 100 mg and 150 mg, on urinary NTx/Cr during the third month of treatment • Effect of oral monthly ibandronate, 100 mg and 150 mg, on the proportion of patients with markers of bone resorption above the pre-specified reference levels • Persistence of the effect of oral monthly ibandronate, 100 mg and 150 mg, on percent change from baseline in the biochemical markers of bone resorption during the first and second month • Safety and tolerability of oral monthly ibandronate, 100 mg and 150 mg, and placebo
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Community-dwelling, ambulatory woman, > 50 years of age and postmenopausal for at least 3 years, with osteoporosis • In a state of general good health • Understands the procedures of the study, has been informed of alternative treatments for osteoporosis, and voluntarily agrees to participate in the study.
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E.4 | Principal exclusion criteria |
•The patient is mentally or legally incapacitated, or otherwise unable to give informed consent. •The patient is a pregnant or lactating woman or a woman of childbearing potential. •The patient has a history of hypersensitivity to any component of ibandronate tablets or the patient has any of the rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. (Ibandronate tablets contain lactose and should not be administered to patients with these conditions.) •The patient has a history of any illness or has significant abnormalities which might either pose an unacceptable risk to the patient from participation in this study or complicate the interpretation of study data. •The patient has an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia. •The patient is unable to stand or sit upright for at least 60 minutes once a month. •The patient is a current user of any illicit drugs or has a history of drug or alcohol abuse within the past five years. •The patient has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary) which may pose an added risk to the patient or impair the patient's ability to complete the trial. •The patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss). •The patient has experienced a clinical fracture in the past year. •The patient has a history of cancer. •The patient is receiving or has received treatment prior to randomization which might influence bone turnover, including: -intravenous or oral bisphosphonate. -parathyroid hormone. -within the past 6 months: estrogen, any estrogen analogue (e.g., raloxifene, tamoxifen), tibolone, aromatase inhibitor or anabolic steroid. Topical (vaginal) estrogen cream (<2 g) used up to two times weekly is acceptable. -thyroid hormone, unless on a stable dose for at least six weeks before randomization with serum TSH within the normal range and no plans to alter the dose during the course of the study. -fluoride at a dose greater than 1 mg/day for more than one month at any time. -strontium ranelate. -glucocorticoid treatment for more than one month with > 5 mg of oral prednisone (or the equivalent) per day within six months prior to randomization. -immunosuppressant treatment (e.g., cyclosporine, azathioprine) within the previous year. •Vitamin A in excess of 10,000 IU per day or Vitamin D in excess of 5000 IU per day, calcitonin, phenytoin, heparin, or lithium.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from Week 9 (one week post dose) at Week 12 (four weeks post dose) in serum CTxI log-transformed fraction from baseline.
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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 | Information not present in EudraCT |
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) | 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 | 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 | Yes |
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
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End of Trial is final visit at week 12. |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |