E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The objective of this study is to collect data on bone histomorphometry, architecture, turnover and material properties from iliac crest biopsies taken from postmenopausal women after > 5 year risedronate treatment. These data will be used as additional data for the primary and secondary objectives from Studies 2003073 and 2003096 for which the recruitment of 28 subjects who had > 5 year risedronate treatment has not been achieved.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031285 |
E.1.2 | Term | Osteoporosis postmenopausal |
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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 objective of this study is to collect data on bone histomorphometry, architecture, turnover and material properties from iliac crest biopsies taken from postmenopausal women after > 5 year risedronate treatment. These data will be used as additional data for the primary and secondary objectives from Studies 2003073 and 2003096.
The objectives of studies 2003073 and 2003096 are:
Primary objective: To determine the differences in iliac crest bone histomorphometry and bone quality (including bone microarchitecture and bone matrix structure) in postmenopausal women who have received long-term (>3 and < 5 years or > 5 years) therapy with alendronate and risedronate
Secondary objective: To determine if iliac crest bone histomorphometry and/or bone quality changes after 5 or more years of therapy with alendronate or risedronate compared to 3 years of alendronate therapy or 3 years of risedronate therapy in postmenopausal women
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women completed the IMPACT study and continued risedronate (any combination of 5 mg daily or 35 mg once weekly) treatment for ≥5 years and are still on risedronate treatment at study entry.
- Self-ambulatory
- In general good health as determined by medical history, physical examination and laboratory tests
- Willing and able to provide written informed consent
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E.4 | Principal exclusion criteria |
- The use of any medication other than risedronate within the past 12 months likely to interfere with skeletal homeostasis, such as estrogen, Selective Estrogen Receptor Modulators, calcitonin, other bisphosphonates, parathyroid hormone, heparin or anticonvulsants
- Use of high dose glucocorticoids (≥ 5 mg/day prednisone or equivalent) for more than one month within 3 months prior to study entry
- Uncontrolled hyperthyroidism
- History of malignancy except treated squamous cell, or basal cell carcinoma of the skin
- Any concurrent disease, which in the opinion of the investigator would inhibit the subject completing the study or would interfere with the outcome measures
- Allergy to tetracycline, Novocain, or Versed
- Hip anatomy not conducive to transiliac bone biopsy or DXA scan
- Previous bilateral transiliac bone biopsies
- Refusal or inability to give informed consent to participate in the study
- Unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, insurmountable language barrier.
- Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Measurements on the bone biopsy are: • Standard static and dynamic histomorphometric parameters. • Collagen cross-linking (from FTIR). • Mineral crystallinity (from FTIR). • Mineralization (from qBEI, synchrotron, micro-CT). • Trabecular and cortical architecture (from micro-CT and synchrotron).
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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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | 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.8.5.1 | Number of sites anticipated in the EEA | 12 |
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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |