Denosumab treatment of postmenopausal women with osteoporosis for 6 years : results from the first 3 years of the freedom extension

in Osteoporosis International (2012, March), 23(S2), 76

Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women.

in Journal of Bone and Mineral Research (2011), 26(2), 397-404

BACKGROUND: Arzoxifene is a selective estrogen receptor modulator (SERM) more potent in preclinical testing than currently available agents. Its effects on clinical outcomes are not known. METHODS: In a ... [more ▼]

BACKGROUND: Arzoxifene is a selective estrogen receptor modulator (SERM) more potent in preclinical testing than currently available agents. Its effects on clinical outcomes are not known. METHODS: In a randomized blinded trial, women age 60 to 85 years with osteoporosis, defined as a femoral neck or lumbar spine bone mineral density T-score less than or equal to -2.5 or a vertebral fracture, and women with low bone mass, defined as a bone density T-score less than or equal to -1.0 and above -2.5, were assigned to arzoxifene 20 mg or placebo daily. The primary endpoints were new vertebral fracture in those with osteoporosis, and invasive breast cancer in the overall population. RESULTS: After 3 years, the cumulative incidence of vertebral fractures in patients with osteoporosis was 2.3% lower in the arzoxifene than in the placebo group, a 41% relative risk reduction (95% CI 0.45 to 0.77; P<0.001). In the overall population, the cumulative incidence of invasive breast cancer over 4 years was reduced by 1.3%, with a 56% relative reduction in risk (HR=0.44; 95% CI 0.26 to 0.76; P<0.001); there was no significant decrease in nonvertebral fracture risk. Arzoxifene increased the cumulative incidence of venous thromboembolic events by 0.7%, with a 2.3-fold relative increase (95% CI 1.5 to 3.7). CONCLUSION: Like other SERMs, arzoxifene decreased vertebral fractures and invasive breast cancer while the risk of venous thromboembolic events increased. (c) 2010 American Society for Bone and Mineral Research. [less ▲]

Safety observations from denosumab long-term extension and cross-over studies in postmenopausal women with osteoporosis

in Journal of Bone and Mineral Research (2011), 26(S1), 22-23