Efficacy of stroncium ranelate versus placebo on the time to fracture healing in osteoporotic men and osteoporotic post-menopausal women

A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women. - The fracture healing study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014271-41-CZ

Enrollment

200

Registered

2010-01-05

Start date

2010-03-16

Completion date

Unknown

Last updated

2013-04-22

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

Conditions

Osteoporotic men and post menopausal osteoporotic women with a fracture of the distal radius MedDRA version: 14.0 Level: LLT Classification code 10031288 Term: Osteoporosis with fracture 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: 135459-90-4 Current Sponsor code: S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Men or postmenopausal women, aged = 50 years - Osteoporotic patient with a fracture of the distal radius (Colles’ 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: - Multiple trauma with serious lesions and/or fractures in other anatomical regions - Known skeletal disease - Displaced fracture - Fracture requiring surgical intervention - Associated fracture of the ulnar shaft - Fracture of the dorsal/volar margin (Barton or reverse Barton fracture). - Volar angulation (Smith fracture or reverse Colles’ fracture). - Vertical fracture and/or fracture of the radial styloid - History or increased risk of venous thrombo-embolism - Known liver insufficiency or renal insufficiency

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficacy of S12911 versus placebo in accelerating radiological healing of distal radius fractures as defined by the bridging in at least 3 out of 4 cortices;Secondary Objective: To demonstrate the efficacy of strontium ranelate in - Enhancing clinical healing - Enhancing early healing - Decreasing the rate of delayed healing - Decreasing the rate of secondary reduction of the fracture - Accelerating radiological healing of distal radius fractures as defined by the bridging in at least 1, 2 and 4 out of 4 cortices - Decreasing the time to the disappearance of the fracture line To assess the safety of strontium ranelate;Primary end point(s): Time to radiological healing defined as bridging in at least 3 out of 4 cortices of the radius;Timepoint(s) of evaluation of this end point: Time to radiological healing over 24 weeks	—

Measure

Time frame

Main Objective: To demonstrate the efficacy of S12911 versus placebo in accelerating radiological healing of distal radius fractures as defined by the bridging in at least 3 out of 4 cortices;Secondary Objective: To demonstrate the efficacy of strontium ranelate in - Enhancing clinical healing - Enhancing early healing - Decreasing the rate of delayed healing - Decreasing the rate of secondary reduction of the fracture - Accelerating radiological healing of distal radius fractures as defined by the bridging in at least 1, 2 and 4 out of 4 cortices - Decreasing the time to the disappearance of the fracture line To assess the safety of strontium ranelate;Primary end point(s): Time to radiological healing defined as bridging in at least 3 out of 4 cortices of the radius;Timepoint(s) of evaluation of this end point: Time to radiological healing over 24 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Other rediological evaluations, Clinical evaluation (functional test, patient reported outcome) Safety evaluation;Timepoint(s) of evaluation of this end point: At all post-baseline visits over 24 weeks	—

Countries

Belgium, Brazil, Czech Republic, Germany, Hungary, Italy, Russian Federation, United Kingdom

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com33 1 55 72 43 66

Outcome results

None listed

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