  Arzoxifene for prevention of fractures and invasive breast cancer in postmenopausal women.; ; Reginster, Jean-Yves  et alin 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 ▲] Detailed reference viewed: 10 (2 ULg)Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards; ; Bruyère, Olivier et alin Osteoporosis International (2011), 22 Summary The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend that a marker of bone formation (serum procollagen ... [more ▼] Summary The International Osteoporosis Foundation (IOF) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommend that a marker of bone formation (serum procollagen type I N propeptide, s-PINP) and a marker of bone resorption (serum C-terminal telopeptide of type I collagen, s-CTX) are used as reference analytes for bone turnover markers in clinical studies. Introduction Bone turnover markers (BTM) predict fracture risk, and treatment-induced changes in specific markers account for a substantial proportion of fracture risk reduction. The aims of this report were to determine their clinical potential in the prediction of fracture risk and for monitoring the treatment of osteoporosis and to set an appropriate research agenda. Methods Evidence from prospective studies was gathered through literature review of the PUBMED database between the years 2000 and 2010 and the systematic review of the Agency for Healthcare Research and Quality up to 2001. Results High levels of BTMs may predict fracture risk independently from bone mineral density in postmenopausal women. They have been used for this purpose in clinical practice for many years, but there is still a need for stronger evidence on which to base practice. BTMs provide pharmacodynamic information on the response to osteoporosis treatment, and as a result, they are widely used for monitoring treatment in the individual. However, their clinical value for monitoring is limited by inadequate appreciation of the sources of variability, by limited data for comparison of treatments using the same BTM and by inadequate quality control. IOF/IFCC recommend one bone formation marker (s-PINP) and one bone resorption marker (s-CTX) to be used as reference markers and measured by standardised assays in observational and intervention studies in order to compare the performance of alternatives and to enlarge the international experience of the application of markers to clinical medicine. Conclusion BTM hold promise in fracture risk prediction and for monitoring treatment. Uncertainties over their clinical use can be in part resolved by adopting international reference standards. [less ▲] Detailed reference viewed: 53 (8 ULg)Effects of arzoxifene on fracture incidence in postmenopausal women with osteoporosis or with low bone massReginster, Jean-Yves ; ; et alin Osteoporosis International (2010, May), 21(Suppl.1), 23-24 Detailed reference viewed: 16 (0 ULg) Oral monthly ibandronate: rationale and clinical potential in postmenopausal osteoporosisReginster, Jean-Yves ; ; et alin Annals of the Rheumatic Diseases (2003, June) Detailed reference viewed: 23 (11 ULg)The effect of risedronate on hip fracture risk in elderly women with osteoporosis; ; Reginster, Jean-Yves et alin Journal of Rheumatology (2001), 28(S63), 24 Detailed reference viewed: 1 (1 ULg)Rapid and sustained hip fracture risk reduction with risedronate in elderly women with osteoporosis; Reginster, Jean-Yves ; et alin BONE (2001), S28 Detailed reference viewed: 19 (1 ULg)Risedronate reduces hip fracture risk in elderly women with osteoporosis; ; et al in Osteoporosis International (2000), 11(S2), 207 Detailed reference viewed: 3 (1 ULg)Rapid and sustained effects of risedronate in reducting hip fracture risk in elderly women with osteoporis; ; et al in Journal of Bone and Mineral Research (2000), 15(S1), 149 Detailed reference viewed: 5 (1 ULg)Risedronate is well-tolerated in women with osteoporosis; ; et al in Journal of Bone and Mineral Research (1999), 14(S1), 538 Detailed reference viewed: 3 (1 ULg)Risedronate reduces hip fractures in patients with low femoral neck bone mineral density; ; et al in Arthritis and Rheumatism (1999), 42(S1), 287 Detailed reference viewed: 3 (2 ULg) |
||
