WASHINGTON, DC -- April 7, 2005 -- A new analysis gives clinicians information to help them more accurately predict future osteoporotic fracture risk in individual patients by combining information from both bone mineral density (BMD) measurements and imaging of the spine.

The analysis, presented at the National Osteoporosis Foundation's Sixth International Symposium on Osteoporosis, showed that at any given BMD, the information from the imaging of the spine was an independent predictor for future vertebral fractures.

"Low BMD is a surrogate for increased fracture risk, but doesn't give the whole story. Imaging the spine allows practitioners to see whether fractures of the spine have actually occurred," said Dr. John Krege, MD, Medical Advisor for Eli Lilly and Company. "Incorporating both BMD and fracture status affords an opportunity to better predict future fracture risk and appropriately treat patients."

This data is important, because women identified as having increased risk for fracture can be treated with lifestyle modifications, fall prevention strategies, medications, and other measures to reduce their risk for future fractures.

Methods

A post hoc analysis looking at data from 2,651 postmenopausal women (1,181 with prevalent vertebral fracture) comprising the placebo groups from two large osteoporosis trials with a median observation of 21 months and two years, respectively, were analyzed to determine the impact of radiographic prevalent vertebral fractures (fractures of the spine visible on radiographs at study baseline) on future vertebral fracture risk independent of BMD. Prevalent vertebral fracture status was defined as:

* The number of prevalent vertebral fractures 0, 1, 2, or greater than or equal to 3
* Maximum semi-quantitative (SQ) deformity grade [Mild - grade 1; Moderate - grade 2; severe - grade 3] (Genant et al. 1993)
* Spinal Deformity Index (SDI) score, an index of spine fracture burden incorporating both number and severity of radiographic vertebral fractures.

Results

The analysis found that for any given BMD, the risk of a new vertebral fracture was approximately increased three to 11-fold in subjects with one or more prevalent radiographic vertebral fractures.

Greater numbers of prevalent vertebral fractures and more severe prevalent vertebral fractures were associated with greater risks for subsequent fracture:

* 2 fractures = ~ 5-fold increase,
* greater than or equal to 3 fractures = 7 to 8-fold increase

Higher prevalent SQ scores were associated with greater risks

* SQ score of 2 = ~ 5-fold increase,
* SQ score of 3 = 8 to 10-fold increase

Similarly, higher prevalent SDI scores were associated with greater risks

* SDI score of 1 to 3 = ~ 3-fold increase,
* SDI score of 4 to 6 = 6 to 7-fold increase,
* SDI score of greater than or equal to 7 = 9 to 11-fold increase