odanacatib

01/01/2021 - "Randomized, controlled trial to assess the safety and efficacy of odanacatib in the treatment of men with osteoporosis."
01/01/2021 - "Incidence of Hip and Subtrochanteric/Femoral Shaft Fractures in Postmenopausal Women With Osteoporosis in the Phase 3 Long-Term Odanacatib Fracture Trial."
01/01/2020 - "In this analysis, the effects of ODN on bone remodeling/modeling and structure were examined in the randomized, double-blind, placebo-controlled, event-driven, Phase 3, Long-term Odanacatib Fracture Trial (LOFT; NCT00529373) and planned double-blind extension in postmenopausal women with osteoporosis. "
01/01/2020 - "Effects of Odanacatib on Bone Structure and Quality in Postmenopausal Women With Osteoporosis: 5-Year Data From the Phase 3 Long-Term Odanacatib Fracture Trial (LOFT) and its Extension."
12/01/2019 - "Based on the overall balance between benefit and risk, the study's sponsor decided that they would no longer pursue development of odanacatib for treatment of osteoporosis. "

01/01/2021 - "Compared with placebo, odanacatib improved bone mineral density and led to sustained bone resorption decreases while producing relatively little bone formation reduction that leveled off with time. "
02/01/2015 - "Its clinical efficacy and safety was confirmed by several clinical studies but indicates that odanacatib is characterized by a resolution-of-effect with increases in bone resorption and rapid decreases in BMD following treatment discontinuation. "
12/01/2017 - "Contrary to active site-directed CatK inhibitors, such as odanacatib, T06 suppresses bone resorption in both human and mouse osteoclasts equally well (IC50 value for human and mouse osteoclasts: 237 ± 60 nM and 245 ± 55 nM, respectively) and its antiresorptive activity is fully reversible in both cell types. "
01/11/2017 - "For safety reasons, odanacatib, an inhibitor of cathepsine K and consecutively of bone resorption will not be available. "
01/01/2016 - "Human osteoclasts and fibroblasts were used to analyse the effect of the exosite inhibitor, ortho-dihydrotanshinone (DHT1), and the active site inhibitor, odanacatib (ODN), on bone resorption and TGF-ß1 degradation. "

01/01/2016 - "Continuous treatment with odanacatib for up to 8 years in postmenopausal women with low bone mineral density: a phase 2 study."
01/01/2016 - "The efficacy and safety of weekly oral odanacatib (ODN) 50 mg for up to 8 years were assessed in postmenopausal women with low bone mineral density (BMD). "
08/01/2013 - "Odanacatib in postmenopausal women with low bone mineral density: a review of current clinical evidence."
11/01/2012 - "Odanacatib in the treatment of postmenopausal women with low bone mineral density: five years of continued therapy in a phase 2 study."
12/01/2016 - "Odanacatib, effects of 16-month treatment and discontinuation of therapy on bone mass, turnover and strength in the ovariectomized rabbit model of osteopenia."

11/01/2015 - "Odanacatib: an emerging novel treatment alternative for postmenopausal osteoporosis."
12/01/2019 - "Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study."
11/01/2015 - "Erratum to: Odanacatib for the treatment of postmenopausal osteoporosis: development history and design and participant characteristics of LOFT, the Long-Term Odanacatib Fracture Trial."
02/01/2015 - "Odanacatib for the treatment of postmenopausal osteoporosis: development history and design and participant characteristics of LOFT, the Long-Term Odanacatib Fracture Trial."
08/01/2013 - "Odanacatib is currently in a phase III fracture outcome international trial for the treatment of postmenopausal osteoporosis. "

01/01/2021 - "However, increased risk of stroke in another study stopped further odanacatib development. "
01/01/2017 - "Although that study demonstrated clinically relevant reductions in fractures at multiple sites, odanacatib was ultimately withdrawn from the regulatory approval process after it was found to be associated with an increased risk of cerebrovascular accidents. "
11/01/2023 - "Odanacatib (ODN), a potential osteoporosis medication, was stopped in the Long-term Odanacatib Fracture Trial (LOFT) phase III study because it increased the risk of stroke. "
12/01/2019 - "Odanacatib reduced the risk of fracture, but was associated with an increased risk of cardiovascular events, specifically stroke, in postmenopausal women with osteoporosis. "
12/01/2019 - "When data from LOFT Extension were included, the composite of cardiovascular death, myocardial infarction, or stroke occurred in significantly more patients in the odanacatib group than in the placebo group (401 [5·0%] of 8043 vs 343 [4·3%] of 8028, HR 1·17, 1·02-1·36; p=0·029, as did stroke (2·3% [187/8043] vs 1·7% [137/8028], HR 1·37, 1·10-1·71; p=0·0051). "