A double-blind, multicentric, multinational randomised study to assess the effects of two years administration of 2 g per day of strontium ranelate versus alendronate 70 mg per week in women with postmenopausal osteoporosis on bone geometry and bone strength measured by peripheral-Quantitative Computed Tomography (p-QCT).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001509-11-SE

Enrollment

148

Registered

2007-09-06

Start date

2007-10-31

Completion date

Unknown

Last updated

2012-07-17

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

Conditions

Post-menopausal osteoporosis MedDRA version: 9.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Women of at least 50 years - Postmenopausal for at least 5 years - Osteoporosis 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: - Evolutive cancers during the past 5 years with a risk of bone metastases - BMI less than 18 or higher than 30 kg/m² - Severe malabsorption

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effects of strontium ranelate in comparison with alendronate (both treatment with calcium and vitamin D supplement) on the bone geometry and bone strength in postmenopausal osteoporotic women.;Secondary Objective: ;Primary end point(s): Measurement of geometrical and bone strength parameters by pQCT.	—

Countries

Germany, Greece, Italy, Sweden

Outcome results

None listed

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