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Actonel Satisfaction in Postmenopausal Osteoporosis
NCT00632216Phase 4
Key facts
- Status
- Completed
- Start
- May 2004
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- risedronate
- Conditions
- postmenopausal osteoporosis
01
Overview
Phase 4, open-label, single-arm trial of risedronate in postmenopausal osteoporosis, sponsored by Sanofi. Primary endpoint: Satisfaction with Actonel 35 mg at 12 weeks. Started May 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Actonel 35mg
Risedronate Sodium 35mg Once a Week
03
Who it enrols
Postmenopausal women aged 55-70 with established osteoporosis (T-score <= -2.5 or vertebral fracture).
04
Endpoints
Primary
Satisfaction with Actonel 35 mg
Secondary
Response rates in CTX (C-telopeptide of type I collagen)
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