Outcomes
Pain, bone pain, pain, vertebral fracture, vertebral deformity
SECONDARY, VITAMIN D DEFICIENCY, TAO
Two bone turnover markers (BTMs), a marker of bone resorption (C-terminal crosslinking telopeptide of type I collagen; CTX) and a marker of bone formation (Procollagen type I N-terminal propeptide; P1NP) were measured at baseline, 6 months, and 12 months. Pain scores at back and bone were evaluated using the numeric rating scale (0 point = no pain; 10 points = worst pain possible) at baseline, 6 months, and 12 months. Bone pain referred to generalized bone pain. DXA with VFA was re-evaluated at 12 months to determine the changes in BMD and degree of vertebral deformity.The primary endpoint was the change of BMD at 12 months. Key secondary endpoints were the change of serum BTMs, back pain, and bone pain score at 12 months. The least significant change (LSC) was defined as more than 25% reduction of serum BTMs compared to baseline. The safety profile of the study drug was evaluated. Other outcomes were the prevalence of vertebral fracture and vitamin D deficiency among patients with TAO.