Efficacy of strontium ranelate versus placebo in postmenopausal osteoporotic women previously treated with bisphosphonates.

• Conditions: Postmenopausal osteoporotic women; MedDRA version: 14.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-000708-17-HU
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-13
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

- Postmenopausal women, aged > or = 50 years
- Osteroporotic patients at high risk for fracture previously treated by bisphosphonate for at least 30 months among the last 5 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified