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In June 2010, denosumab was approved by the FDA for use in postmenopausal women with risk of osteoporosis [31] under the brand name Prolia, [32] and in November 2010, as Xgeva for the prevention of skeleton-related events in people with bone metastases from solid tumors. [33] Denosumab is the first RANKL inhibitor to be approved by the FDA. [31]
In large studies, women taking bisphosphonates for osteoporosis have had unusual fractures ("bisphosphonate fractures") in the femur (thigh bone) in the shaft (diaphysis or sub-trochanteric region) of the bone, rather than at the femoral neck, which is the most common site of fracture. However, these fractures are rare (12 in 14,195 women ...
Servier states that the use is now restricted to treatment of severe osteoporosis in postmenopausal women at high risk for fracture. [2] The European Pharmacovigilance Risk Assessment Committee (PRAC) recommended restriction in the use of strontium ranelate, based on a routine benefit-risk assessment of the medicine, which included data showing ...
Raloxifene increases bone mineral density in postmenopausal women but decreases it in premenopausal women. [14] In the MORE trial, the risk of vertebral fractures was decreased by 30%, and bone mineral density was increased in the spine (by 2.1% at 60 mg, 2.4% at 120 mg) and femoral neck (2.6% at 60 mg, 2.7% at 120 mg). [ 20 ]
Osteoporosis can affect nearly 1 in 3 women and the bone loss is the most rapid within the first 2–3 years after menopause. This can be prevented by menopause hormone therapy or MHT, which is meant to prevent bone loss and the degradation of the bone microarchitecture and is noted to reduce the risk of fractures in bones by 20-30%.
The International Osteoporosis Foundation and the European Calcified Tissue Society recommend pharmacological therapy for osteoporosis in postmenopausal women and men ≥70 years, with a previous fragility fracture, or a dose equivalent of prednisone ≥7.5 mg daily for ≥3 months. For premenopausal women and men <50 years taking steroids for ...
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