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The efficacy and safety of 2g strontium ranelate in the treatment of osteoporosis in men. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.

The efficacy and safety of 2g strontium ranelate in the treatment of osteoporosis in men. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004717-17-EE
Enrollment
221
Registered
2007-01-11
Start date
2007-03-26
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Osteoporosis in men MedDRA version: 9.1 Level: PT Classification code 10031282 Term: Osteoporosis

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

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: · The following BMD criterion: Mean lumbar spine BMD or femoral neck BMD or total femur BMD corresponding to a T-score lower than –2.5SD of the young healthy male reference population OR Mean lumbar spine BMD or femoral neck BMD or total femur BMD corresponding to a T-score lower than –1.5SD of the young healthy male reference population plus a prevalent low impact fracture during adulthood · Caucasian males of at least 65 years of age (with no upper age limit) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: · Bone mineral density T-score below –4.0 at one or more of the measured sites · More than two prevalent mild and/or moderate osteoporotic vertebral fractures · Severe osteoporotic vertebral fracture . Other criteria (detailed in the protocol)

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate the efficacy of strontium ranelate over 1 year compared to placebo in men with osteoporosis on lumbar BMD;Secondary Objective: . To demonstrate the efficacy on hip BMD and bone markers and safety of strontium ranelate over 1year compared to placebo in men with osteoporosis . A secondary analysis will be performed after a follow up period of an additional year of treatment;Primary end point(s): · Bone Mineral Density (BMD) at the lumbar spine—

Countries

Czech Republic, Denmark, Estonia, Lithuania

Outcome results

None listed

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