E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 assess the effect of i.v. ibandronate (3 mg Bonviva ® every 3 months for 24 months) on Avg-MIN (average mineralization, gm/cm³) and Peak-MIN (peak mineralization, gm/cm³) as measured by QBEI analyses in osteoporotic men. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of i.v. ibandronate
1. on trabecular and cortical thickness.
2. on trabecular number.
3. on trabecular connectivity.
4. on lumbar spine, total hip, femoral neck, trochanter, total body and distal forearm BMD.
5. on biochemical markers of bone resorption.
6. on biochemical markers of bone formation.
7. on indices of calcium and mineral homeostasis.
8. on measures of static and dynamic histomorphometry in transilial bone biopsy specimens.
9. on bone microarchitecture as assessed by 3-D microCT scans of transilial bone biopsy specimens.
10. To assess the levels of RNA expression of OPG , RANKL, runx2, OSX, sclerostin, wnt10b , osteocalcin within bone samples of the study population.
11. To assess the compliance of osteoporotic men during treatment with i.v. ibandronate.
12. To assess the safety of i.v. ibandronate in osteoporotic men.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) The patient is a man aged from 20 to 85 years.
b) The patient has a T-score of ≤ -2 at the femoral neck and a T-score of ≤ -1 at the lumbar spine or has a T-score of ≤ -1 at the femoral neck and at least one moderate vertebral deformity (meeting the Genant criteria) or at least one non-vertebral low trauma fracture , .
c) The patient’s lumbar spine is suitable for dual-energy x-ray absorptiometry (DXA) At least 2 vertebrae between L1 and L4 are measurable. (i.e. not fractured or filled with cement etc.) NOTE: Fractured vertebrae must be excluded from measurement and therefore do not account for the patient’s lumbar spine BMD.
d) The patient’s 25-hydroxyvitamin D level is ≥ 10 ng/ml. Note: Rescreening is allowed in case of vitamin D deficiency; if rescreening takes places earlier than 6 months after the baseline visit DXA, X-ray and ECG must not be repeated); otherwise the entire screening procedure must be completed.
e) The patient does not suffer from any metabolic bone disease OTHER THAN primary osteoporosis/osteopenia OR osteoporosis/osteopenia associated with low testosterone levels.
f) The patient has sufficiently been informed about the study procedures including bone biopsy. He is able and willing to give his written consent.
g) The patient agrees not to use any antiosteoporotic medications except those provided by this study. (Calcium and vitamin D supplements can in case of product intolerance be changed to equivalent or similar preparations.)
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E.4 | Principal exclusion criteria |
a) The patient has received or receives any of the following medications: (a) oral bisphosphonates within the last 6 months, (b) i.v. bisphosphonates at any time, (c) anabolic steroids or glucocorticoids (≥ 5 mg prednisone equivalent for more than 2 weeks within the last 6 months, (d) fluorides at any time (except fluorides for dental prophylaxis) , (e) strontiumranelate at any time, (f) PTH at any time, (g) current use of antiepileptic substances or thyroid hormones (i) recently initiated androgen replacement therapy (Note: Patients on stable androgen levels under ongoing androgen replacement therapy for at least 6 months will be allowed)
b) The patient has taken either calcitonin and/or SERMs within the last 6 months.
c) Both hips of the patient are unsuitable for DXA. (e.g. hip replacements)
d) The patient suffers from thyroid hypo- or hyperfunction .His TSH is beyond the given range of 0,27 – 4,20 μU/ml.
e) The patient has a history of prior malignancy within the last five years; (exception basal cell carcinoma)
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Hypothesis
I.v. ibandronate (3 mg Bonviva ® every 3 months for 24 months) will significantly increase Avg-MIN (average mineralization, gm/cm³) and Peak-MIN (peak mineralization, gm/cm³) in osteoporotic men.
Secondary Hypothesis
1. I.v. ibandronate will significantly increase trabecular and cortical thickness, trabecular number and trabecular connectivity in osteoporotic men.
2. I.v. ibandronate will significantly increase lumbar spine, total hip, femoral neck, trochanter, total body and distal forearm BMD in osteoporotic men.
3. I.v. ibandronate will significantly decrease indices of bone resorption and bone formation in osteoporotic men.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | No |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | 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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Last visit of last subject (n = 20) |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |