E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal osteoporotic women |
|
E.1.1.1 | Medical condition in easily understood language |
Postmenopausal osteoporotic women |
|
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 | 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 demonstrate the effect of strontium ranelate versus placebo of treatment on the areal bone mineral density (BMD) of the lumbar spine in postmenopausal women with osteoporosis previously treated with bisphosphonates. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effects of strontium ranelate on :
- areal BMD of the hip and femoral neck
- bone geometry, strength and structure
- bone turnover
- clinical and biological safety |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Postmenopausal women, aged > or = 50 years
- Osteroporotic patients at high risk for fracture |
|
E.4 | Principal exclusion criteria |
- Patients with at least one of the following DXA related criteria in reference to the lowest BMD value at any relevant site (L1-4, total hip, femoral neck):≤ -4.0 SD T-score, > -1.5 SD T-score in patients with prevalent osteoporotic fractures, > -2.0 SD T-score in patients without prevalent osteoporotic fractures
- Patients with two or more clinical osteoporotic fractures within the last 3 years
-Current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
- Current or previous venous thromboembolism events, including deep vein thrombosis and pulmonary embolism, or patients at high risk of venous thromboembolism.
- Temporary or permanent immobilzation due to e.g. post-surgical recovery or prolonged bed rest.
- BMI <18 or > 32 kg/m²
- Skeletal disease other than primary osteoporosis
- Sarcoidosis
- Phenylketonuria
- Hypersensitivity to the active substance or to any of the excipients, hypersensitivity to soy or peanuts
- Hereditary fructose intolerance, glucose-galactose malabsorption, saccharase isomaltase deficiency
- Severe renal insufficiency |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Lumbar areal Bone Mineral Density (L1-L4) assessed by DXA |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Hip BMD assessed by DXA
Bone geometry and bone strength parameters
Bone structure parameters
Bone markers
Assessment of adverse events
Biological parameters evaluation
Clinical examination
Vertebral Fracture Assessment |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | No |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 9 |