E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Postmenopausal Osteoporosis | |
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 demonstrate that zoledronic acid 5 mg i.v. given annually at randomization and Month 12 is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I (women < 5 years from menopause) and in Stratum II (women ≥ 5 years from menopause) - To demonstrate that zoledronic acid 5 mg i.v. given at randomization only is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I and in Stratum II | |
E.2.2 | Secondary objectives of the trial | To assess the percent change in BMD at the lumbar spine at Months 6, 12 and 18 relative to baseline in each strata comparing: a) zoledronic acid 5 mg i.v. given at randomization and Month 12 to placebo b) zoledronic acid 5 mg i.v. given at randomization only to placebo c) zoledronic acid 5 mg i.v. given at randomization only to zoledronic acid 5 mg i.v. given at randomization and Month 12 (including Month 24 for this comparison) To assess the percent change in BMD at the total hip, femoral neck, trochanter, and distal radius at Months 6, 12, 18, and 24 relative to baseline in each strata comparing: (a), (b) and (c) - see above. To assess the change of biochemical markers of bone resorption and formation at Months 1, 3, 6, 9, 12, 15, 18, and 24 relative to baseline in each strata comparing: (a), (b) and (c) - see above. To evaluate the overall safety and tolerability of zoledronic acid compared to placebo. | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | Women greater than or equal to 45 years of age inclusive at the time of randomization, considered postmenopausal according to one of the following guidelines: • cessation of menses for 18 months in women < 50 years of age • cessation of menses for 12 months in women age 50 years or over • documented bilateral oophorectomy at least 1 year previously Women with osteopenia defined as Bone Mineral Density T-score less than -1.0 and greater than - 2.5 at the lumbar spine Bone Mineral Density T-score value greater than -2.5 at the femoral neck | |
E.4 | Principal exclusion criteria | Patiens with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate) Patients with any Grade 2 or 3 vertebral fracture (as per Genant method) Patients with 25-(OH) Vitamin D levels less than 15 ng/mL prior to randomization Renal insufficiency (calculated creatinine clearance less than 30.0 mL/min) at Visit 1 or Visit 2 Hypercalcemia (serum calcium ≥ 2.75 mmol/L (11.0 mg/dL) at Visit 1 Hypocalcemia (serum calcium ≤ 2.0 mmol/L (8.0 mg/dL) at Visit 1 AST or ALT greater than 2.0 times the upper limit of normal Serum alkaline phosphatase greater than 1.5 times the upper limit of normal | |
E.5 End points |
E.5.1 | Primary end point(s) | Change of BMD at the lumbar spine. | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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) | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | 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 | |
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 | Last visit of the last patient undergoing the trial. | |
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 | 1 |
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 | 1 |