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PERSPECTIVES: Protelos® for postmenauposal osteoporotic patients with previous therapies

PERSPECTIVES: Protelos® for postmenauposal osteoporotic patients with previous therapies - an observational prospective multi-centre study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN80637249
Enrollment
2250
Registered
2009-05-15
Start date
2009-02-02
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Postmenopausal osteoporosis Musculoskeletal Diseases Osteoporosis without pathological fracture

Interventions

1. To get information on the evolution of osteoporosis therapy in the treatment postmenopausal osteoporosis via standardised documentation 2. To get information on comobidity and comed

Sponsors

Servier Deutschland GmbH (Germany)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Postmenopausal osteoporotic women, treated with strontium ranelat (Protelos®).

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Efficacy under routine conditions: ordinal scale (very good, good, moderate, bad) 2. Tolerability: ordinal scale (very good, good, moderate, bad) 3. Pain (VAS; 0 = no pain - 10 = unbearable pain) 4. Fractures (standardized documentation) 5. Quality of life (patients questionnaire including 9 questions = ordinal scale) 6. Compliance, persistence, adherence (standardised patients questionnaire) All data will be assessed at initiation visit and 3 months later at final visit.

Secondary

MeasureTime frame
No secondary outcome measures

Countries

Germany

Outcome results

None listed

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