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Teriparatide vs Risedronate in Severe Postmenopausal Osteoporosis
NCT01709110Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2012
- Primary completion
- Jul 2016
- Countries
- 15
- Sponsor
- Eli Lilly and Company
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- teriparatide
- Conditions
- postmenopausal osteoporosis
01
Overview
Phase 4, randomised, double-blind trial of teriparatide in postmenopausal osteoporosis (2 arms), sponsored by Eli Lilly and Company. Primary endpoint: Proportion of Participants With New Vertebral Fractures at 24 months. Started Oct 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Teriparatide
Teriparatide 20 mcg SC daily + Placebo oral weekly
Risedronate
Risedronate 35 mg oral weekly + Placebo SC daily
03
Who it enrols
Postmenopausal women with severe osteoporosis defined by low BMD (T-score <= -1.5) and at least 2 moderate or 1 severe vertebral fragility fractures.
04
Endpoints
Primary
Proportion of Participants With New Vertebral Fractures
Secondary
Proportion of Participants With Pooled New and Worsening Vertebral Fractures
Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures
Proportion of Participants With Non-Vertebral Fragility Fractures
Change From Baseline to 24 Months Endpoint in Height
Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale
Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L]
05
Results
Primary endpoints met
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