NCT01839682 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Chin DK, Park JY, Yoon YS, Kuh SU, Jin BH, Kim KS, Cho YE
Prevalence of osteoporosis in patients requiring spine surgery: incidence and significance of osteoporosis in spine disease. Osteoporos Int. 2007 Sep;18(9):1219-24. Epub 2007 Mar 27.
Ledlie JT, Renfro MB
Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine (Phila Pa 1976). 2006 Jan 1;31(1):57-64. Erratum in: Spine. 2006 Jun 15;31(14):1635.

Prospective, Single Arm, Open Label Post-Market Pilot Study to Evaluate the StabiliT Vertebral Augmentation System Treat Vertebral Compression Fractures Due to Osteoporosis

Details for clinical trial NCT01839682

Clinical trial NCT01839682 - References