The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013935-39-FI

Enrollment

500

Registered

2009-10-26

Start date

2009-12-28

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic men and postmenauposal women MedDRA version: 12.0 Level: LLT Classification code 10031283 Term: Osteoporosis fracture MedDRA version: 12.0 Level: LLT Classification code 10031285 Term: Osteoporosis postmenopausal

Interventions

Product Name: S06911 Product Code: S06911 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: strontium ranelate CAS Number: 135459-90-4 Current Sponsor code: S12911 Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Osteoporotic men and postmenopausal osteoporotic women - Superior or equal to 50 year - Caucasian - Body mass index inferior to 30 kg/m2 - 25-OH vitamin D concentration >22.5 nmol/L 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Progressive major illness, uncontrolled active disease, skeletal disease - History or increased risk of deep venous thrombosis or pulmonary embolism - History of intolerance, allergy or severe hypersensitivity with study drugs - History of alcohol abuse or drug dependance

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of S6911 after 3 months of treatment;Secondary Objective: - To assess the efficacy of S6911 on vitamin D insufficiency - To collect information on safety and tolerability of S6911;Primary end point(s): Vitamin D levels.	—

Countries

Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Poland, Slovakia, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026