The Effect of 3 or 6 Years of Denosumab Exposure in Women With Postmenopausal Osteoporosis: Results From the FREEDOM Extension.
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in The Journal of clinical endocrinology and metabolism (2013)
Context:The FREEDOM extension is evaluating the long-term efficacy and safety of denosumab for up to 10 years.Objective:Report results from the first 3 years of the extension, representing up to 6 years ... [more ▼]
Context:The FREEDOM extension is evaluating the long-term efficacy and safety of denosumab for up to 10 years.Objective:Report results from the first 3 years of the extension, representing up to 6 years of denosumab exposure.Design, Setting, and Participants: Multicenter, international, open-label study of 4550 women.Intervention:Women from the FREEDOM denosumab group received 3 more years of denosumab for a total of 6 years (long-term) and women from the FREEDOM placebo group received 3 years of denosumab (cross-over).Main Outcome Measures:Bone turnover markers (BTMs), bone mineral density (BMD), fracture, and safety.Results:Reductions in BTMs were maintained (long-term) or achieved rapidly (cross-over) following denosumab administration. In the long-term group, BMD further increased for cumulative 6-year gains of 15.2% (lumbar spine) and 7.5% (total hip). During the first 3 years of denosumab treatment, the cross-over group had significant gains in lumbar spine (9.4%) and total hip (4.8%) BMD, similar to the long-term group during the 3-year FREEDOM trial. In the long-term group, fracture incidences remained low and below rates projected for a "virtual placebo" cohort. In the cross-over group, 3-year incidences of new vertebral and nonvertebral fractures were similar to those of the FREEDOM denosumab group. Incidence rates of adverse events did not increase over time. Six participants had events of ONJ confirmed by adjudication. One participant had a fracture adjudicated as consistent with atypical femoral fracture.Conclusion:Denosumab treatment for 6 years remained well tolerated, maintained reduced bone turnover, and continued to increase BMD. Fracture incidence remained low. [less ▲]Detailed reference viewed: 28 (2 ULg)
Long-term denosumab treatment of postmenopausal women with osteoporosis: results from the first year extension study of the FREEDOM trial
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in Arthritis and Rheumatism (2010, October), 62(10), 903Detailed reference viewed: 57 (1 ULg)
Osteonecrosis of the jaw and bisphosphonate treatment for osteoporosis.
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in BONE (2008), 42(5), 841-7
A potential side effect associated with bisphosphonates, a class of drugs used in the treatment of osteoporosis, Paget's disease and metastatic bone disease, is osteonecrosis of the jaw (ONJ). The ... [more ▼]
A potential side effect associated with bisphosphonates, a class of drugs used in the treatment of osteoporosis, Paget's disease and metastatic bone disease, is osteonecrosis of the jaw (ONJ). The incidence of ONJ in the general population is unknown; this rare condition also may occur in patients not receiving bisphosphonates. Case reports have discussed ONJ development in patients with multiple myeloma or metastatic breast cancer receiving bisphosphonates as palliation for bone metastases. These patients are also receiving chemotherapeutic agents that might impair the immune system and affect angiogenesis. The incidence or prevalence of ONJ in patients taking bisphosphonates for osteoporosis seems to be very rare. No causative relationship has been unequivocally demonstrated between ONJ and bisphosphonate therapy. A majority of ONJ occurs after tooth extraction. Furthermore, the underlying risk of developing ONJ may be increased in osteoporotic patients by comorbid diseases. Treatment for ONJ is generally conservative. [less ▲]Detailed reference viewed: 30 (2 ULg)