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Teriparatide for Incomplete Atypical Femur Fractures
NCT01896011Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2013
- Primary completion
- Dec 2021
- Countries
- 1
- Sponsor
- University Health Network
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- teriparatide
- Conditions
- atypical femur fracture (AFF)
01
Overview
Phase 3, randomised, double-blind trial in atypical femur fracture (AFF) comparing Teriparatide with Placebo (2 arms). Primary endpoints: Change in the modified Western Ontario and McMaster Universities Osteoarthritis Index at 12 months and Proportion of patients requiring surgical intervention at 12 months. Started Jul 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Teriparatide
Teriparatide 20 mcg daily
Placebo
Placebo daily
03
Who it enrols
Patients over 30 with incomplete atypical femur fractures (AFF) confirmed by radiography. Excludes patients with peri-prosthetic fractures, high trauma fractures, pathological fractures from metastases or metabolic bone diseases other than osteoporosis, severe renal impairment, multiple myeloma, primary hyperparathyroidism, hypercalcemia, Paget's disease, or prior skeletal radiation. Concomitant use of bisphosphonates or denosumab is excluded.
04
Endpoints
Primary
Change in the modified Western Ontario and McMaster Universities Osteoarthritis Index
Proportion of patients requiring surgical intervention
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