E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporosis; Aortic Calcification |
|
E.1.1.1 | Medical condition in easily understood language |
Osteoporosis; Aortic Calcification |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054208 |
E.1.2 | Term | Aortic calcification |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10031285 |
E.1.2 | Term | Osteoporosis postmenopausal |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia. |
|
E.2.2 | Secondary objectives of the trial |
- To examine the relationship between BMD and aortic calcification
- To investigate the potential clinical utility of the two non-invasive techniques of PWV measurements and lateral DXA scans of the spine for measuring AC by direct comparison with the gold standard of CT.
- To investigate the association between AC and several of the important endocrine and molecular factors that have been implicated in the link between osteoporosis and AC.
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Ambulatory postmenopausal women.
Aged 50 years and over.
Lumbar spine, femoral neck or total hip bone mineral density measurement more than 2 standard deviations below the young adult mean for healthy women (T-score < -2).
Normal or clinically insignificant laboratory values. |
|
E.4 | Principal exclusion criteria |
Current or recent (within 1 year of enrolment) metabolic bone disorders other than postmenopausal osteoporosis including Paget's disease, renal osteodystrophy, osteomalacia or any other disease known to influence bone metabolism.
Treatment with oestrogens, progestins or selective estrogen receptor modulators (SERMS) for longer than 3 months in the past or within 3 months of study enrolement.
Previous or current use of oral or intravenous bisphosphonates.
Current treatment with corticosteroids, calcitonins, strontium ranelate, anticonvulsants, vitamin D >50,000IU/week, teripatide, PTH 1-84 or any other treatment known to influence bone metabolism.
Current use of lipid lowering agents.
Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia
Hypersensitivity to alendronic acid or to any of the excipients
Hypocalcaemia
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes in pulse wave velocity (aortic stiffness).
Changes in aortic calcification. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, month 3, month 6, month 12, month 18, month 24 |
|
E.5.2 | Secondary end point(s) |
To investigate the potential clinical utility of the two non-invasive techniques of PWV measurements and lateral DXA scans of the spine for measuring AC by direct comparison with the gold standard of CT. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, month 6, month 12, month 18, month 24 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Calcium and vitamin D supplements |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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
|
Last visit of the last subject undergoing trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |