E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal Osteoporosis |
|
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 |
|
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 |
Assessing whether previous treatment of osteoporosis with a bisphosphonates affects the subsequent response to treatment with Strontium Ranelate.
|
|
E.2.2 | Secondary objectives of the trial |
Assessment of the relative merits of different established techniques for monitoring the response of osteoporotic patients to Strontium Ranelate.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) - Age: 50-75
2) - T score: <-2.5 at either hip or spine or a T score <2.0 and one BMD independent risk factor for fracture (previous osteoporotic fracture, maternal osteoporotic fracture, previous steroid use, BMI <19, untreated premature menopause) (typical criteria for patients considered as requiring treatment to reduced their risk of fracture).
3)-Fit into group 1 or 2 below: Group1: no previous bisphosphonates. Group 2: > 1 year treatment with oral bisphosphonates and stopped treatment within the last 1 month due to lack of effect or side effects. Also if treated with pamidronate for > 1 year and last infusion within the last 3 month. (to allow clear distinction between the study groups)
|
|
E.4 | Principal exclusion criteria |
Significant renal disease. (creatinine clearance < 30 ml/min) Prior treatment with Strontium Ranelate. Active malignancy Osteomalacia Primary hyperparathyroidism Patient is unable to give informed consent
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The change from baseline in bone mineral density at 1 year will be compared between the 2 groups.
At the end of the first year subjects will be offered the chance to enter into the second year of the study. Informed consent will be taken for the second year. The drug treatment will remain the same but there will be 2 extra vists at 18 and 24 months. The end point for this extention will be bone mineral density at year 2 compared between the 2 groups.
|
|
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 | 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 | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
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 |
Same drug, different population groups |
|
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 Trial lasts 1 year and ends when the last subject completes their last visit.
The extention phase lasts for 1 further year and ends when the last subject completes their last visit |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |