Teriparatide is associated with a lower risk for new vertebral and clinical fractures compared with risedronate in postmenopausal women being treated for severe osteoporosis, according to a multicenter double-blind study published in The Lancet.
Researchers randomly assigned 1360 postmenopausal women with at least 2 moderate or 1 severe vertebral fractures and a bone mineral density T score less than or equal to –1.50 to receive either 20 µg teriparatide subcutaneously once daily plus oral weekly placebo or 35 mg oral risedronate once weekly plus daily injections of placebo.
After 24 months of treatment, only 5.4% (28/680) of patients in the teriparatide group experienced new vertebral fractures compared with 12.0% (64/680) of patients in the risedronate group (P <.001).
Likewise, the incidence of clinical fractures was lower in the teriparatide group compared with the risedronate group (4.8% vs 9.8%, respectively; P =.0009) as well as the incidence of nonvertebral fragility fractures (4.0% vs 6.1%, respectively; P =.10). The incidence of adverse events was similar in both groups and both drugs were well tolerated.
This is the largest 24-month trial using the approved dose of teriparatide in postmenopausal women with osteoporosis and it is also the first double-dummy active-controlled head-to-head trial comparing 2 osteoporosis medications with fracture risk as the primary outcome.
“These data show that teriparatide is better at preventing fractures in patients with severe osteoporosis, and confirm previous data from clinical trials of teriparatide versus bisphosphonates with fracture as a secondary end point,” the investigators concluded. “Clinicians should consider teriparatide for optimal management for patients with osteoporosis who have prevalent vertebral fractures.”
Kendler DL, Marin F, Zerbini CAF, et al. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomized controlled trial [published online November 9, 2017]. Lancet. doi:10.1016/S0140-6736(17)32137-2