Osteologix Reports Trial Results for NB S101
Osteologix’s NB S101, a treatment for osteoarthritis, met its primary endpoint by significantly decreasing CTX-1, a well-validated biomarker for measuring bone resorption activity, in a Phase II trial.
The 12-week, double-blind, randomized, placebo and active-controlled STRONG trial evaluated three dose levels of NB S101 (strontium malonate) and one dose level of Protelos (strontium ranelate) in 289 postmenopausal women with low bone mineral density.
The reductions in serum CTX-1 compared with the control group were 13.5 percent in the group receiving the 0.75 g of NB S101, 15.5 percent in the group receiving 1 g and 22.2 percent in the group receiving 2 g, Osteologix said.
Protelos demonstrated a statistically significant reduction in CTX-1 of 8.5 percent at the 2-gram dose. When compared with Protelos, the 2-gram dose of NB S101 achieved significantly greater reductions of CTX-1, while the 1-gram dose produced equivalent reductions.
The trial also investigated the effects of NB S101 on bone mineral density (BMD) at specific sites, including lumbar spine, total hip and femoral neck. At three months, NB S101 significantly increased lumbar spine BMD at all doses.