Prevent Recurrence of Osteoporotic Fracture (PROOF) Study

Introduction

Study characteristics:

• randomized, controlled, double blind trial of inhaled (nasal) salmon calcitonin 100, 200 or 400 IU
• all received 1000 mg of calcium + 400 IU vitamin D QD

• 1255 postmenopausal women with established osteoporosis
• 1-5 vertebral fractures
• bone mineral density T scores < -2

Results:

• 200 IU: 33% reduction in vertebral fractures
• 100 or 400 IU:
  • 15% (non significant) reduction in vertebral fractures
  • No significant effect on bone mineral density or vertebrae or hip

More general terms

• clinical trial

Additional terms

• bone mineral density (BMD)
• calcitonin; contains: katacalcin; calcitonin carboxyl-terminal peptide; CCP; PDN-21 (CALC, CALC1)
• osteoporosis
• vitamin D