E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporosis in post-menopausal women |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031285 |
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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 objective is to study the efficacy of a single-dose monthly dosing regimen (150 mg monthly, referred to in this protocol as the Monthly Regimen) of risedronate, compared to the standard daily dosing regimen (5 mg daily, referred to in this protocol as the Daily Regimen) of risedronate, in order to assess the non-inferiority of the Monthly Regimen to the Daily Regimen, as determined by the percentage change from Baseline in lumbar spine BMD at 12 months in women with postmenopausal osteoporosis. |
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E.2.2 | Secondary objectives of the trial |
• change from Baseline in lumbar spine BMD at Month 12 • change and percentage change from Baseline in lumbar spine BMD at Months 6, 24, and endpoint • percentage of responders at Months 12 and 24 • change and percentage change from Baseline in BMD of the total proximal femur, femoralneck, and trochanter at Months 6, 12, 24, and endpoint • change and percentage change from Baseline in bone resorption and bone formation markers at Months 3, 6, 12, 24, and endpoint • number of patients with at least one new vertebral body fracture at Months 12, 24, and endpoint • change from Baseline in patient-reported outcomes at Months 12 and 24. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a) be female, ambulatory, and 50 years of age or older; b) be in generally good health; c) be postmenopausal (≥ 5 years since last menses, natural or surgical); d) have at least 3 evaluable lumbar spine vertebral bodies (L1-L4), namely without fracture or degenerative disease; e) meet one of the following lumbar spine BMD criteria: • have lumbar spine BMD (L1-L4) less than 0.772 g/cm2 (Hologic) or 0.880 g/cm2 (Lunar), corresponding to a BMD more than 2.5 SD below the young adult female mean value, or • have lumbar spine BMD (L1-L4) less than 0.827 g/cm2 (Hologic) or 0.940 g/cm2 (Lunar), corresponding to a BMD more than 2.0 SD below the young adult female mean value, and at least one prevalent vertebral body fracture (T4-L4); f) be willing and able to provide written informed consent. |
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E.4 | Principal exclusion criteria |
a) any previous or ongoing clinically significant illness b) abuse of alcohol, c) abuse of prescription or illicit drugs, d) any condition or disease that may interfere with the evaluation of lumbar spine BMD as determined in a Screening radiograph by a radiologist at the central e) bilateral hip prostheses; f) history of hyperparathyroidism, g) uncontrolled hyperthyroidism or ongoing osteomalacia at the time of enrollment; h) any history of cancer within past 5 years, except for basal cell carcinoma and dermalsquamous cell carcinoma with documented 6-month remission. Patients with a recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission; i) a Body Mass Index > 32 kg/m2; j) any known allergic or abnormal reaction to bisphosphonates; k) use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug: • oral glucocorticoids ≥ 5 mg prednisone or equivalent/day; • anabolic steroids • estrogens except for low dose vaginal creams, tablets or insertable estrogen ring • progestins • calcitonin • vitamin D supplements (> 1000 IU per day) • calcitriol, calcidiol, or alfacalcidol at any dose • any bisphosphonate • fluoride (≥ 10 mg/day) • strontium (≥ 50 mg/day) • PTH • products in the phytoestrogen or isoflavone classes l) depot injection > 12,000 IU vitamin D in the past 9 months; m) markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the Investigator (Appendix 1); n) creatinine clearance of < 30 mL/min, o) hypocalcemia or hypercalcemia from any cause; p) serum thyroid stimulating hormone (TSH) value outside the permissible range of 0.38-9.99 mU/L. ( q) serum 25-hydroxy vitamin D level < 12 ng/mL (30 nmol/L); r) participation in another clinical trial 30 days prior to Screening; s) demonstrated poor likelihood of completing the study and complying with protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage change from Baseline in lumbar spine BMD at 12 months in women with postmenopausal osteoporosis. |
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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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
5mg risedronate (Actonel/Optinate) |
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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 |
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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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The study is considered terminated upon completion of all patient protocol-scheduled treatments and evaluations. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |