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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031282 |
E.1.2 | Term | Osteoporosis |
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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 |
The primary objectives are to demonstrate the superiority of treatment with zoledronic acid Calcium and Vitamin D relative to placebo Calcium and Vitamin D regarding the percent change of BMD at lumbar spine and/or total hip at Month 12 relative to baseline as measured by DXA. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives include the evaluation of the following parameters in male osteoporotic patients treated with zoledronic acid Calcium and Vitamin D compared to those treated with placebo Calcium and Vitamin D To demonstrate the superiority of treatment with zoledronic acid Calcium and Vitamin D relative to placebo Calcium and Vitamin D regarding the percent change of BMD at lumbar spine and/or total hip at Month 6 and relative to baseline as measured by DXA. To demonstrate the superiority of treatment with zoledronic acid Calcium and Vitamin D relative to placebo Calcium and Vitamin D regarding the percent change of BMD at femoral neck at Month 6 and Month 12 relative to baseline as measured by DXA. To assess changes in biochemical markers of bone resorption and bone formation at Month 3, 6 and 12 relative to baseline in patients treated with zoledronic acid Calcium and Vitamin D pls see protocol |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male patients between 50 and 85 years of age, inclusive Bone mineral density T-score of less than or equal to -2.5 SD at the total hip or femoral neck AND less than or equal to -1.5 SD at the lumbar spine as confirmed by the central expert reader |
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E.4 | Principal exclusion criteria |
Patients with 25- OH Vitamin D levels less than 15 ng/mL at Visit 1. If the vitamin D level is 15 ng/ml the patient should receive a loading dose of 75,000-100,000 IU of vitamin D i.m. or orally once at Visit 1 and have the vitamin D test repeated at Visit 1A to be done after at least 3 weeks have passed . Baseline renal insufficiency calculated creatinine clearance less than 30.0 mL/min at Visit 1 and/or Visit 1A Serum calcium less than or equal to 2.0 mmol/L 8.0 mg/dL at Visit 1 or Visit 1A AST or ALT greater than three times the upper limit of normal Serum alkaline phosphatase greater than 1.5 times the upper limit of normal Any disease or deformation of the spine that would preclude the proper acquisition of a lumbar spine DXA L1-L4 e.g. implantable devices, scoliosis, ankylosing spondylitis |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objectives are to demonstrate the superiority of treatment with zoledronic acid Calcium and Vitamin D relative to placebo Calcium and Vitamin D regarding the percent change of BMD at lumbar spine and/or total hip at Month 12 relative to baseline as measured by DXA. |
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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 | Information not present in EudraCT |
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 | 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 | 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 | 7 |
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 | 7 |