6/30/23, 2:22 AM Teriparatide for glucocorticoid-induced osteoporosis Pathway Feedback Search Clinical Topics Home Studies Teriparatide for glucocorticoid-induced osteoporosis Teriparatide for glucocorticoid-induced osteoporosis Disease Corticosteroid-induced osteopo Trial question What is the effect of teriparatide in patients with corticosteroid-induced osteoporosis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 81.0% female N = 428 19.0% male 428 patients (345 female, 83 male) Inclusion criteria: women and men with osteoporosis (ages, 22 to 89 years) who had received corticosteroids for at least 3 months (prednisone equivalent, 5 mg daily) Key exclusion criteria: unresolved skeletal diseases other than corticosteroid-induced osteoporosis, an increased risk of osteosarcoma, gastrointestinal disorders that would likely reduce tolerance of oral alendronate, or substantial renal impairment Interventions N=214 teriparatide (20 g once daily) N=214 alendronate (10 mg once daily) Primary outcome https://web.pathway.md/studies/rec399HJ3PKJElJTx 1/2 6/30/23, 2:22 AM Teriparatide for glucocorticoid-induced osteoporosis Pathway Improvement of bone mineral density at lumbar spine 7.2 % 7.2 5.4 % 3.6 % 3.4 Significant increase 1.8 % NNT = 26 0.0 % Teriparatide Alendronate Significant increase in improvement of bone mineral density at the lumbar spine (7.2% vs. 3.4%; RR 2.12, 95% CI 0.86 to 3.38) Secondary outcomes Significant decrease in vertebral fractures (0.6% vs. 6.1%; RR 0.1, 95% CI 0.03 to 0.17) Significant increase in change in bone mineral density at the total hip, at 18 months (3.8% vs. 2.4%; RR 1.59, 95% CI 0.48 to 2.7) Safety outcomes No significant differences in adverse event (85.0% vs. 79.4%, p=0.11) and serious adverse event (21.0% vs. 18.2%, p=0.44). Significant differences in hypercalcemia, at least one serum calcium level > 10.5 mg/dL (18.0% vs. 5.7%, p < 0.001). Conclusion In women and men with osteoporosis (ages, 22 to 89 years) who had received corticosteroids for at least 3 months (prednisone equivalent, 5 mg daily), teriparatide was superior to alendronate with respect to improvement of bone mineral density at the lumbar spine. Reference Saag KG, Shane E, Boonen S et al. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. Open reference URL https://web.pathway.md/studies/rec399HJ3PKJElJTx 2/2