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 | PT |
E.1.2 | Classification code | 10031282 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
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 |
2.1.1 Primary (1) Objective: To assess the effect of odanacatib 50 mg once weekly versus placebo on lumbar spine BMD over 24 months. 2) Objective: To assess the safety and tolerability of odanacatib 50 mg once weekly compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
-To assess the effect of treatment with odanacatib 50 mg once weekly on the total hip, femoral neck, and trochanter BMD compared to placebo over 24 months. -To assess the effect of treatment with odanacatib 50 mg once weekly on biochemical indices of bone resorption (serum C-Telopeptides of Type 1 collagen and urine N-Telopeptides of Type 1 collagen) compared to placebo over 24 months. -To assess the effect of treatment with odanacatib 50 mg once weekly on biochemical indices of bone formation (serum bone-specific alkaline phosphatase and serum N-terminal propeptide of type 1 collagen) compared to placebo over 24 months. -To assess the effect of treatment with odanacatib 50 mg once weekly on the lumbar spine, total hip, femoral neck, and trochanter BMD compared to placebo over 36 months. -To assess the effect of treatment with odanacatib 50 mg once weekly on biochemical indices of bone resorption and on biochemical indices of bone formation compared to placebo over 36 months. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: Il protocollo prevede anche uno studio di farmacogenomica. Per maggiori dettagli si rinvia al protocollo pagg. 30-31.
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E.3 | Principal inclusion criteria |
(1) Male between 40 and 95 years of age; (2) Patient has idiopathic osteoporosis or osteoporosis due to hypogonadism and fulfils one of the following BMD critieria: (a) patient is a candidate for osteoporosis therapy and has BMD T-score ≤ - 2.5 at either the lumbar spine (LS) or the total hip or any hip subregion (femoral neck or trochanter) and a BMD T-score ≥ - 4.0 at all sites and does not have a prior vertebral fracture (b) patient is a candidate for osteoporosis therapy and has BMD T-score ≤ - 1.5 at either the LS or the total hip or any hip subregion (femoral neck or trochanter) and a BMD T-score ≥ - 4.0 at all sites and has one prior vertebral fracture OR (c) patient is not a candidate for, or has declined osteoporosis therapy and has BMD T-score ≤ - 2.5 at either the LS or the total hip or any hip subregion (femoral neck or trochanter) and does not have a prior vertebral fracture; or has BMD T-score ≤ - 1.5 at either the LS or the total hip or any hip subregion (femoral neck or trochanter), and has at least one prior vertebral fracture; (3) Patient has lumbar spine anatomy suitable for DXA. Specifically, at least 2 vertebral bodies in the L1 to L4 region must be assessable; (4) Patient is ambulatory. |
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E.4 | Principal exclusion criteria |
(1) Patient has chosen treatment with oral bisphosphonates or other agents for the treatment of osteoporosis (2) Patient has a prior fragility hip fracture and is a suitable candidate for osteoporosis therapy ( i.e., bisphosphonates, parathyroid hormone (PTH) ); (3) Patient has experienced a fragility fracture (including any vertebral fracture) within 12 months, documented by medical record, or detected on the screening spine radiographs read locally, unless the patient is unwilling to take, or is not a candidate for marketed osteoporosis therapy (4) Patient has had more than 1 prior vertebral fracture and he is a suitable candidate for osteoporosis therapy (5) Patient has evidence of a metabolic bone disorder other than osteoporosis (6) Patient has vitamin D deficiency, defined as serum 25-hydroxyvitamin D < 15 ng/ml; (7) Patient has history of renal stone, and serum calcium, serum 25-hydroxyvitamin D and serum PTH are not all within normal limits (8) Patient has active parathyroid disease (9) Patient has history of thyroid disease not adequately controlled by medication (10) Patient has secondary osteoporosis due to celiac disease, malabsorption, rheumatoid arthritis, systemic inflammatory disease, mastocytosis or HIV infection (11) Patient has serum-creatinine >1.6 mg/dL and is considered to have severe renal insufficiency(12) Patient has a history of malignancy ≤ 5 years prior to signing of informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
BMD percent change from baseline at lumbar spine at Month 24. |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 | Yes |
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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Lo studio e` diviso in due parti, l’analisi primaria per questi endpoints sara` effettuata dopo 24 mesi di trattamento (Parte1); tuttavia, i soggetti resteranno nello studio per altri 12 mesi e continueranno il farmaco in studio (Parte 2). |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |