E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of Post-menopuasal Osteoporosis |
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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 | 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 |
Assess the non-inferiority of risedronate, administered as a 35mg DR weekly regimen administered immediately following breakfast, compared to the 5mg IR daily regimen administered at least 30 minutes before breakfast as determined by % change from baseline in lumbar spine BMD at Week 52. If, and only if the weekly regimen is non-inferior to the daily regimen, assess the non-inferiority of the 35mg DR weekly risedronate formulation, administered at least 30 minutes before breakfast, compared to the 5mg IR daily risedronate formulation, administered at least 30 minutes before breakfast, as assessed by % change from baseline in lumbar spine BMD at Week 52 |
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E.2.2 | Secondary objectives of the trial |
Evaluate efficacy of the DR regimens in change from baseline in lumbar spine BMD at Week 52 Evaluate efficacy of the DR regimens by change and % change from baseline in lumbar spine BMD at Weeks 26, 52 and 104 If both DR weekly regimens are non-inferior to the 5mg IR daily regimen as above, the pooled DR results will be assessed on % change from baseline in lumbar spine BMD at Week 52 to show superiority of the DR weekly regimen Evaluate efficacy of the DR regimens by change and % change from baseline in BMD of total proximal femur, femoral neck and greater trochanter at Week 26, 52 and 104 Evaluate efficacy of the DR regimens by change and % change from baseline in BTMs (CTX, NTX, BAP) at Weeks 13, 26, 52 and 104 Determine the % of responders (patients who show a postive change [>0g/cm2]in lumbar spine BMD ar Week 52 and 104 Determine the % of patients with at least 1 new vertebral body fracture at Week 52 and 104 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
female, ambulatory and 50 years of age or older in good health as determined by the investigator be postmenopausal(>=5 years since last menses) FSH and estradiol levels are evaluated for any patient < 65 years and who has undergone hysterectomy without bilateral oophorectomy, levels must be serum FSH >=40 mIU/ml and estradiol <=20pg/ml have at least 3 evaluable lumbar spine vertebral bodies meet one of the following BMD criteria: lumbar spine BMD <0.772 g/cm2 (Hologic) or 0.694 g/cm2 (Lunar) or total hip BMD <0.637 g/cm2 (Hologic) or <0.694 g/cm2 (Lunar), i.e BMD > 2.5SD below young adult mean OR lumbar spine BMD <0.827 g/cm2 (Hologic) or 0.940 g/cm2 (Lunar) or total hip BMD <0.709 g/cm2 (Hologic) or <0.768 g/cm2 (Lunar), i.e BMD > 2.0SD below young adult mean and at least one prevalent vertebral fracture written informed consent |
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E.4 | Principal exclusion criteria |
previous or ongoing clinically significant illness abuse of alcohol, prescription or illicit drugs any condition or disease that may interfere with evaluation of lumbar spine BMD bilateral hip prostheses hyperparathyroidism unless sugically corrected and normal serum calcium levels 12 months prior to enrollment uncontrolled hyperthyroidism or ongoing osteomalacia history of cancer in last 5 years except basal cell carcinoma and dermal squamous cell carcinoma with 6-month remission BMI >32 kg/m2 known allergy or intolerance to bisphosphonates or any of the excipients use of IV bisphosphonates within 12 months any use of following medications within 3 months of study, or use greater than 1 month 3-6 months prior to study: anabolic steroids, estrogens (except low dose), progestins, calcitonin, vit D supplements (>1200 IU per day), calcitriol, calcidiol or alfacalcidol, bisphosphonates, fluoride >=10mg daily, PTH and teriperatide, glucocorticoid use as defined in the protocol and a depot injection of vit D >12,000 IU in the past 9 months abnormal clinical laboratory results, including creatinine clearance, hypocalcaemia, hypercalcaemia, TSH and serum 25-hydroxy vitamin D as defined in the protocol participation in another clinical trial 30 days prior to screening BMD <5.0SD below young adult female mean value use of any anticonvulsant within 1 month or use for more than 1 month within 6 months of study start postive fecal occult blood testing history of inflammatory bowel disease, malabsorption or sprue; use (even 1 dose) of strontium (>=50 mg/day) within 6 months prior to the first dose of study drug or for more than 3 months at any time in the past 10 years |
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E.5 End points |
E.5.1 | Primary end point(s) |
The % change from baseline in lumbar spine BMD at Week 52 |
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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 | 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 | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |