E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoporotic men and post menopausal osteoporotic women with a fracture of the distal radius |
|
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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031288 |
E.1.2 | Term | Osteoporosis with fracture |
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 demonstrate the efficacy of S12911 versus placebo in accelerating radiological healing of distal radius fractures as defined by the bridging in at least 3 out of 4 cortices |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate the efficacy of strontium ranelate in
- Enhancing clinical healing
- Enhancing early healing
- Decreasing the rate of delayed healing
- Decreasing the rate of secondary reduction of the fracture
- Accelerating radiological healing of distal radius fractures as defined by the bridging in at least 1, 2 and 4 out of 4 cortices
- Decreasing the time to the disappearance of the fracture line
To assess the safety of strontium ranelate |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men or postmenopausal women, aged ≥ 50 years
- Osteoporotic patient with a fracture of the distal radius (Colles’ fracture)
|
|
E.4 | Principal exclusion criteria |
- Multiple trauma with serious lesions and/or fractures in other anatomical regions
- Known skeletal disease
- Displaced fracture
- Fracture requiring surgical intervention
- Associated fracture of the ulnar shaft
- Fracture of the dorsal/volar margin (Barton or reverse Barton fracture).
- Volar angulation (Smith fracture or reverse Colles’ fracture).
- Vertical fracture and/or fracture of the radial styloid
- History or increased risk of venous thrombo-embolism
- Known liver insufficiency or renal insufficiency
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to radiological healing defined as bridging in at least 3 out of 4 cortices of the radius |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time to radiological healing over 24 weeks |
|
E.5.2 | Secondary end point(s) |
Other rediological evaluations,
Clinical evaluation (functional test, patient reported outcome)
Safety evaluation |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At all post-baseline visits over 24 weeks |
|
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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
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 | No |
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 |
Belgium |
Brazil |
Czech Republic |
Germany |
Hungary |
Italy |
Russian Federation |
United Kingdom |
|
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
|
LVLP as stated in the protocol. |
|
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |