New data have shown that Forteo ( Teriparatide; Forsteo ) significantly increased lumbar spine volumetric bone mineral density ( vBMD ) compared to Risedronate ( Actonel ) in men with glucocorticoid-induced osteoporosis.
Glucocorticoid-induced osteoporosis is caused by excess intake of glucocorticoids, a class of steroid hormones used to treat inflammatory, autoimmune and allergic disorders.
Study results are published in the Journal of Bone and Mineral Research.
Results from the study's primary endpoint showed that at 18 months, both Teriparatide and Risedronate significantly increased lumbar spine vBMD, and greater increases were observed in patients taking Teriparatide ( mean change from baseline: 16.3% vs. 3.8%; p=0.004 ).
Measurement was completed using conventional and high-resolution quantitative computed tomography ( QCT ), a newer technology that uses modern clinical scanners to provide tri-dimensional BMD and bone structural evaluations. QCT is better able to discriminate between subjects with and without prevalent vertebral fractures compared to conventional areal dual X-ray absorptiometry ( DXA ) and is better suited to identify patients with glucocorticoid-induced osteoporosis at highest risk for fracture.
Secondary outcomes observed in the study include:
a significant increase in estimated vertebral strength in both treatment groups, with statistically higher increases in patients taking Teriparatide ( 26.0% to 34.0% ) compared to Risedronate ( 4.2% to 6.7% ) ( p less than 0.005 );
a trend toward higher bone volume fraction in patients taking Teriparatide ( mean change from baseline: +23.1% vs +7.3%; p=0.098 );
a significant increase in microstructural bone tissue variables derived from high-resolution QCT, such as cortical thickness and trabecular numbers in patients taking Teriparatide and Risedronate, with no significant differences between the two groups; differences between treatments in the change from baseline in biochemical markers of bone turnover, with significant increases in bone formation marker ( PINP ) in patients taking Teriparatide ( up to 175% ), and suppression ( -30% ) in patients taking Risedronate;
a significant increase in areal BMD at the lumbar spine and the total hip after 18 months of treatment for both groups, with statistically significantly higher increases for Teriparatide at the lumbar spine ( mean: +6.94% vs. +3.33%; p=0.045 ), and at the femoral neck ( mean: +1.52% vs -1.10%; p=0.026 );
a trend toward fewer clinical fractures in patients taking Teriparatide ( 0/45, 0% ) compared to patients taking Risedronate ( 5/47, 10.6% ) ( p=0.056 );
and no statistically significant safety differences between the groups.
Teriparatide is used in both men and postmenopausal women with osteoporosis who are at high risk for having fractures. Teriparatide is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as Prednisone, for several months, who are at high risk for having fractures.
Teriparatide can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.
EuroGIOPS Trial was an 18-month randomized, open-label, controlled trial conducted in four European countries in men who had taken glucocorticoids ( steroids ) for more than three months ( Prednisone equivalent greater than 5 mg/die ) and had an areal bone mineral density ( BMD ) T-score less than -1.5 SD. Participants received either 20 mg/die Teriparatide ( n=45 ) or 35 mg/wk Risedronate ( n=47 ) and 1 g Calcium and 1200 IU Vitamin-D daily. ( Xagena )
Source: Lilly, 2013