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

A 24 months, prospective, randomized, double-blind study to assess the effect of daily oral administration of 2 g of strontium ranelate versus placebo on bone mineral density in postmenopausal osteoporotic women previously treated with bisphosphonates

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000708-17-DE

Enrollment

160

Registered

2011-08-08

Start date

2011-08-30

Completion date

Unknown

Last updated

2015-02-16

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

Conditions

Postmenopausal osteoporotic women MedDRA version: 16.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: PROTELOS Product Name: S12911 Product Code: S12911 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: Strontium ranelate CAS Number: 135459-87-9 Current Sponsor code: S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Postmenopausal women, aged > or = 50 years - Osteoporotic patients at high risk of fracture previously treated by bisphosphonate for at least 30 continous 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

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 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 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 - current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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;Primary end point(s): Lumbar areal Bone Mineral Density (L1-L4) assessed by DXA ;Timepoint(s) of evaluation of this end point: Every 6 months	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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;Primary end point(s): Lumbar areal Bone Mineral Density (L1-L4) assessed by DXA ;Timepoint(s) of evaluation of this end point: Every 6 months

—

Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: At least each 6 months	—

Countries

Austria, Belgium, Germany, Hungary

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33 155 72 43 66

Outcome results

None listed

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