E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
osteoporosis cardiovascular disease |
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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 |
We aim to determine whether one of the most commonly prescribed drugs for osteoporosis; bisphosphonates; also confer beneficial cardiovascular effects through effects on the cholesterol synthesis pathway |
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E.2.2 | Secondary objectives of the trial |
This study aims to clarify if impaired endothelial function; an important step in coronary heart disease; contributes to increased cardiovascular risk in postmenopausal women with osteoporosis |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria: • Postmenopausal women aged 45 to 60 years of age. • T score at or below -2.5 standard deviations of the mean on DEXA scan.
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E.4 | Principal exclusion criteria |
Exclusion Criteria: • Women who are pregnant, lactating, not undertaking an acceptable form of contraception, have hypocalcaemia or severe renal impairment (a creatinine clearance less than 30ml/min) • Menopause before the age of 40 or surgical menopause. • Bone disorders other than osteoporosis. • Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, lithium or anticonvulsants • Previous treatment with bisphosphonates or steroids. • Systolic blood pressure of >140 mm Hg or diastolic blood pressure >90 mm Hg at baseline screening examination determined as a mean of 3 readings. • History of myocardial infarction, angina, peripheral vascular disease, cerebrovascular disease or diabetes mellitus (fasting blood sugar >7.0mmol/l). • History of gastritis or gastro-oesophageal reflux disease. • Significant co-morbidity, malignancy or secondary causes of osteoporosis
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcomes: significant increase in platelet NO bioavailability and decrease in O2- production. Secondary outcomes: increased vascular reactivity and endothelium dependant vasodilatation, down regulation of Rac and Rho activity, NO synthase and NAD(P)H oxidase: reduced platelet activation, and reduction in serial measurements of bone markers |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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 | Yes |
E.8.2.3 | Other | No |
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
|
the last visit of the last patient after 24 weeks of therapy |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |