Osteoporosis increases fracture risk, especially in metaphyseal bone.
Fractures seriously impair function and quality of life and incur large direct
and indirect costs. Although the prevention of fractures is certainly the
option, a fast and uneventful healing process is optimal when fractures do
occur. Many new therapeutic strategies have been developed to accelerate
fracture-healing or to diminish the complication rate during the course of
fracture-healing. However, widely accepted guidelines are needed to
demonstrate the positive or negative interactions of bioactive substances,
drugs, and other agents that are being used to promote fracture-healing. For
each study design, the primary study goal should be indicated. Outcome
variables should include both objective and subjective parameters. The
guidelines should be harmonized between European and American regulatory
authorities to ensure comparability of results of studies and to foster global
harmonization of regulatory requirements.