NCT02916953 - 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)

Abrahamsen B, van Staa T, Ariely R, Olson M, Cooper C
Excess mortality following hip fracture: a systematic epidemiological review. Osteoporos Int. 2009 Oct;20(10):1633-50. doi: 10.1007/s00198-009-0920-3. Epub 2009 May 7.
International Osteoporosis Foundation
Facts and Statistics. 2013: http://www.iofbonehealth.org/facts-statistics.
Kanis JA, Oden A, Johansson H, Borgstrom F, Strom O, McCloskey E
FRAX and its applications to clinical practice. Bone. 2009 May;44(5):734-43. doi: 10.1016/j.bone.2009.01.373. Epub 2009 Feb 3.
MacLean C, Newberry S, Maglione M, McMahon M, Ranganath V, Suttorp M, Mojica W, Timmer M, Alexander A, McNamara M, Desai SB, Zhou A, Chen S, Carter J, Tringale C, Valentine D, Johnsen B, Grossman J
Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med. 2008 Feb 5;148(3):197-213. doi: 10.7326/0003-4819-148-3-200802050-00198. Epub 2007 Dec 17.

Clinical Evaluation of the Safety of a Local Osteo-Enhancement Procedure (LOEP™) Intended to Increase Bone Strength in the Proximal Femur of Women in Europe With Osteoporosis

Details for clinical trial NCT02916953

Clinical trial NCT02916953 - References