SOTI and TROPOS phase III studies open-label extension. The long term efficacy and long term safety assessment of a five-year oral administration of strontium ranelate in osteoporotic postmenopausal women having participated either in Spinal Osteoporosis Therapeutic Intervention "SOTI" study or TReatment Of Peripheral OSteoporosis "TROPOS" study. A five-year multicentric multinational open study with strontium ranelate.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN48348637

Enrollment

3000

Registered

2008-05-16

Start date

2002-09-09

Completion date

Unknown

Last updated

2018-05-21

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

Conditions

Postmenopausal osteoporosis Musculoskeletal Diseases Postmenopausal osteoporosis

Interventions

All participants will take 2 g per day of strontium ranelate for five years.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Caucasian women 2. Postmenopausal 3. Osteoporosis 4. Having participated up to the SOTI or TROPOS M060 visit or withdrawn under study treatment from the SOTI or TROPOS study within a 6-month period preceding the theoretical M060 visit

Exclusion criteria

Exclusion criteria: 1. Patients having attended the M060 or withdrawn SOTI-TROPOS visit at a time greater than one year prior to the inclusion visit of the CL3-12911-012 protocol 2. Significant concomitant disease (evolutive major illnesses) 3. Severe disease interfering with bone metabolism

Design outcomes

Primary

Measure	Time frame
The following will be assessed annually during the treatment: 1. Dual X-ray absorptiometry (DXA) 2. Vertebral fractures radiographs in patients having had vertebral radiographs in SOTI or TROPOS 3. Occurrence of peripheral fractures	—

Secondary

Measure	Time frame
Safety	—

Countries

Australia, Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom

Outcome results

None listed

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