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Finally, the two-year extension results from the FREEDOM trial five years of denosumab administration in total for the denosumab group and a crossover group with two years of denosumab exposure indicated that infectious events did not increase nor decrease with long-term administration of denosumab.


Suboptimal tissue specificity may also raise concerns for cancer. In fact, osteoprotegerin binding to TRAIL, which is a survival factor for tumor cells, may interfere with a natural defense mechanism against tumorigenesis. However, metaanalyses of randomized, placebo-controlled trials failed to detect a statistically significant difference. Suboptimal tissue specificity may also be the case for eczema and allergic skin reactions, including dermatitis and rashes.

Their coordination on the skin epithelium results in activation of T regulatory cells and control over contact hypersensitivity and autoimmune response. The deranging effect of RANKL inhibition by denosumab could amplify cutaneous allergic and inflammatory responses and lead to skin hypersensitivity. In the first 2 years of FREEDOM extension, rates of skin-related events were similar to or lower than those in the denosumab group during the core trial. It is an issue of significant concern, because abdominal aortic calcification detected on lateral spine images from a bone densitometer was found to predict incident myocardial infarction and stroke in older women.

Unfortunately, pharmacologic manipulation of osteoprotegerin levels by denosumab in humans has not been extensively investigated and no evidence regarding this effect on vascular calcification has been published to date. As previously specified, the second class of safety concerns largely results from an exaggerated effect of denosumab on bone remodeling. Denosumab is a potent antiosteoclastic agent, as documented by the rapid and persistent suppression of bone markers after its subcutaneous administration at low and even undetectable levels.

Hypocalcemia was reported as an adverse event in 1. It is worth stating that patients with impaired renal function were at an increased risk for this effect. Overall, it appears that the attributable risk is extremely low, at least for patients with osteoporosis. It is worth stating that the pathogenesis of osteonecrosis of the jaw is not straightforward, and several hypotheses, implicating also a role of macrophages, 67 vascularity, and bacterial infection of the area have been proposed.

Furthermore, denosumab discontinuation is reported to restore bone markers rapidly to pretreatment levels, while in both the FREEDOM trial 31 and its two-year extension, 30 the increases in bone markers at the end of the dosing interval appeared to increase with time in the study. This is not the case for the concern regarding the effect of denosumab on fracture healing, a concern that was raised early in the development of pharmacologic RANKL inhibition.

The question concerning whether coupling and osteoclast depletion via RANK blockade would affect callus formation and maturation and matrix remodeling was tested early using RANK-Fc therapy in mice, and no adverse effects on fracture healing were observed when therapy was discontinued. In summary, it appears that denosumab is a rather safe choice for all subgroups of patients with postmenopausal osteoporosis, with the exception of those with chronic kidney disease stage 5 and hepatic dysfunction.

Place in osteoporosis treatment As mentioned before, denosumab is an antiresorptive compound with anti-fracture efficacy at all skeletal sites and, although direct comparative studies with fracture endpoints are lacking, completed trials with established surrogates suggest an effect at least similar to that of zoledronic acid.

Therefore, it could be used as first-line antiresorptive treatment in patients with severe newly diagnosed osteoporosis. However, it is likely that most patients with severe osteoporosis have already been treated with another antiresorptive agent; thus, denosumab could be considered in cases of previous antiresorptive treatment failure.

Additionally, denosumab could be used as an alternative treatment option in patients with intolerance of oral bisphosphonates. Furthermore, given that osteoporosis is a chronic condition, and prolonged administration of bisphosphonates has raised concerns about rare but serious adverse events limiting their safe use at 5—10 years, 2 denosumab represents an alternative with the potential for more prolonged administration than bisphosphonates, even if they are effective and well tolerated.

Finally, given that antiresorptive treatment following parathyroid hormone teriparatide [PTH 1—34] or full-length PTH 1—84 treatment 74 preserves or further increases BMD, denosumab could be used sequential to synthetic parathyroid hormone.

The cost-effectiveness of denosumab has been evaluated by estimating the cost per quality-adjusted life-year gained. Analyses have shown that denosumab is cost-effective in postmenopausal women with low bone mass compared with no treatment 75 or treatment with oral bisphosphonates, 76 and therefore has the potential to be a first-line treatment for postmenopausal women with osteoporosis. As expected, the cost-effectiveness of denosumab is favorable, particularly in patients at high risk of fracture or with low expected adherence to oral treatments.

First, denosumab represents a distinct class of antiresorptives because it inhibits osteoclast maturation in the early stages of development and osteoclast activity, rather than impairing viability of osteoclasts. Second, it is not incorporated into bone mineral. Therefore, the mode of action of denosumab is mainly characterized by reversibility of its effect after cessation of treatment, in contrast with bisphosphonates which can exert an antifracture effect for several years after their discontinuation.

Third, denosumab is metabolized via the reticuloendothelial system and not through the kidneys. Therefore, in patients with severe kidney dysfunction, particular attention should be paid to ensuring that patients are calcium-replete and vitamin D-replete prior to treatment initiation and supplementing with calcium and vitamin D during treatment.

In addition, patients with severe kidney disease may also have metabolic bone diseases that mimic osteoporosis clinically but be other forms of renal bone disease renal osteodystrophy , where a different management strategy may be required. Finally, gastrointestinal side effects, one of the most common causes for poor compliance with oral bisphosphonates, are lacking with denosumab. Thus, denosumab has a likelihood of long-term adherence similar to that of the intravenous bisphosphonates.

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