Efficacy of strontium ranelate in the management of long bone fractures

Effect of strontium ranelate (2g per day) in the management of long bone fractures with delayed-union or non union: an international open label study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017039-16-CZ

Enrollment

Registered

2010-03-03

Start date

2010-05-05

Completion date

Unknown

Last updated

2014-04-14

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

Conditions

Delayed and non-united fractures MedDRA version: 14.1 Level: PT Classification code 10017088 Term: Fracture nonunion System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1 Level: PT Classification code 10017081 Term: Fracture delayed union 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: Men aged 18 years and postmenopausal women with a fracture of the limb or clavicle with delayed union, defined as an absence of radiological full union after 6 months according to investigator’s opinion OR with Non-union defined as non-union for at least 6 months and no sign of radiological healing or bone reaction since at least 3 months, Ambulatory prior to the qualifying fracture. 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 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13

Exclusion criteria

Exclusion criteria: Not pathological fracture, Bone-related disease other than osteoporosis, Septic or synovial or congenital pseudarthrosis, Fracture with a fracture gap, after reduction or treatment, greater than more the half the width of the affected bone, Concomitant treatments interfering with bone metabolism, History of venous thrombo-embolism, History of intolerance, allergy or hypersensitivity to strontium ranelate, Contraindication to Calperos D3.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effects of strontium ranelate in the management of aseptic fractures with delayed union or non-union.;Secondary Objective: Not applicable;Primary end point(s): Radiological state at the fractured site asessessed by radiography, Time to progression, Algofunctional behaviour of the affected limb, Pain intensity using a Visual Analogue Scale of 10 cm, Full recovery to walk and improvement to walk, Secondary surgical interventions, Quality of Life, Improvement in mobility, Safety. ;Timepoint(s) of evaluation of this end point: 1. Radiological union of the fracture, performed every 2 or 3 months during the study 2. Clinical assessments (including pain, quality of life, mobility, etc.), performed performed every 2 or 3 months during the study (mobility test performed every 6 months) 3. Safety evaluations, performed every 2 or 3 months during the study	—

Measure

Time frame

Main Objective: To assess the effects of strontium ranelate in the management of aseptic fractures with delayed union or non-union.;Secondary Objective: Not applicable;Primary end point(s): Radiological state at the fractured site asessessed by radiography, Time to progression, Algofunctional behaviour of the affected limb, Pain intensity using a Visual Analogue Scale of 10 cm, Full recovery to walk and improvement to walk, Secondary surgical interventions, Quality of Life, Improvement in mobility, Safety. ;Timepoint(s) of evaluation of this end point: 1. Radiological union of the fracture, performed every 2 or 3 months during the study 2. Clinical assessments (including pain, quality of life, mobility, etc.), performed performed every 2 or 3 months during the study (mobility test performed every 6 months) 3. Safety evaluations, performed every 2 or 3 months during the study

—

Secondary

Measure	Time frame
Secondary end point(s): No secondary outcome measures ;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Brazil, Czech Republic, France, Germany, Hungary, Italy, Romania

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33 1 55 72 43 66

Outcome results

None listed

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