Randomized, Double-Blind Study of Denosumab Versus Zoledronic Acid in the Treatment of Bone Metastases in Patients With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma

Henry, David H.; Costa, Luís; Goldwasser, François; Hirsh, Vera; Hungria, Vânia; Prausová, Jana; Scagliotti, Giorgio Vittorio; Sleeboom, Harm; Spencer, Andrew; Vadhan‐Raj, Saroj; Moos, Roger von; Willenbacher, Wolfgang; Woll, Penella J.; Wang, Jianming; Jiang, Qi; Jun, Susie; Dansey, Roger; Yeh, Hong‐Zen

doi:10.1200/jco.2010.31.3304

Cited by 1,081 publications

(728 citation statements)

References 36 publications

Supporting

Mentioning

660

Contrasting

Unclassified

Order By: Relevance

“…It has been noted that the risk of MRONJ in cancer patients exposed to denosumab is comparable to the risk of MRONJ in patients exposed to zolendronate, (70 up to 90 cases per 10,000 patients) (5,10,12,13).…”

Section: Mronj Was First Reported In 2003 But Its Pathophysiologymentioning

confidence: 95%

See 1 more Smart Citation

Surgery Combined with LPRF in Denosumab Osteonecrosis of the Jaw: Case Report

et al. 2016

View full text Add to dashboard Cite

This paper describes two cases in which the use of leucocyte-rich and platelet-rich fibrin (LPRF) combined with bone resection did not result in complete tissue response in the treatment of medication-related osteonecrosis of the jaw (MRONJ). It has been recently described in patients receiving subcutaneous administration of RANK-inhibitors, such as Denosumab, and anti-angiogenic drugs, such as Bevacizumab, as observed in our cases. Due to promising results in recent studies, more patients will receive these medications in order to avoid skeletal complications due to metastatic bone disease and, therefore, this scenario has a potential to become a comparable challenge to the bisphosphonateinduced jaw necrosis in the area of Oral and Maxillofacial Surgery. No convincing surgical technique has been described to overcome the non-healing mucosal lesions with exposed bone due to RANK-inhibitor therapy. Based on the findings in the literature and in both cases described herein can be concluded that the use of LPRF should be considered in the treatment of patients with DRONJ. S u r g e r y C o m b i n e d w i t h L P R F i n D e n o s u m a b O s t e o n e c r o s i s o f t h e J a w : C a s e R e p o r t

show abstract

Section: Mronj Was First Reported In 2003 But Its Pathophysiologymentioning

confidence: 95%

“…In addition, LPRF leukocytes pursue an immune regulation, which may be important in preserving tissue infection in the immediate postoperative period (13). The mature and dense LPRF fibrin network allows the storage of cells such as platelets, so that there is slow release of growth factors (29).…”

Section: Discussionmentioning

confidence: 99%

Surgery Combined with LPRF in Denosumab Osteonecrosis of the Jaw: Case Report

et al. 2016

View full text Add to dashboard Cite

show abstract

“…As with zoledronic acid, high-dose denosumab treatment for cancer was associated with higher rates of ONJ than that with osteoporosis doses. (78,79) No cases of atypical femur fractures have been reported, but data are limited to 5 years in the FREEDOM extension and are only a short time postmarketing.…”

Section: Safety Of Denosumabmentioning

confidence: 99%

Postmenopausal osteoporosis treatment with antiresorptives: Effects of discontinuation or long-term continuation on bone turnover and fracture risk—a perspective

Boonen¹,

Ferrari²,

Miller³

et al. 2012

Journal of Bone and Mineral Research

View full text Add to dashboard Cite

Osteoporosis may be a lifelong condition. Robust data regarding the efficacy and safety of both long-term osteoporosis therapy and therapy discontinuation are therefore important. A paucity of clinical trial data regarding the long-term antifracture efficacy of osteoporosis therapies necessitates the use of surrogate endpoints in discussions surrounding long-term use and/or discontinuation. Long-term treatment (beyond 3-4 years) may produce further increases in bone mineral density (BMD) or BMD stability, depending on the specific treatment and the skeletal site. Bisphosphonates, when discontinued, are associated with a prolonged reduction in bone turnover markers (BTMs), with a very gradual increase to pretreatment levels within 3 to 60 months of treatment cessation, depending on the bisphosphonate used and the prior duration of therapy. In contrast, with nonbisphosphonate antiresorptive agents, such as estrogen and denosumab, BTMs rebound to above pretreatment values within months of discontinuation. The pattern of BTM change is generally mirrored by a more or less rapid decrease in BMD. Although the prolonged effect of some bisphosphonates on BTMs and BMD may contribute to residual benefit on bone strength, it may also raise safety concerns. Adequately powered postdiscontinuation fracture studies and conclusive evidence on maintenance or loss of fracture benefit is lacking for bisphosphonates. Similarly, the effects of rapid reversal of bone turnover upon discontinuation of denosumab on fracture risk remain unknown. Ideally, studies evaluating the effects of long-term treatment and treatment discontinuation should be designed to provide head-to-head ''offset'' data between bisphosphonates and nonbisphosphonate antiresorptive agents. In the absence of this, a clinical recommendation for physicians may be to periodically assess the benefits/risks of continuation versus discontinuation versus alternative management strategies. ß

show abstract

“…Dans un essai de phase III comparant le dénosumab à l'acide zolédronique dans le traitement du cancer avec métastases osseuses (à l'exception du cancer du sein et du cancer de la prostate), un sous-groupe de patients inscrits à cet essai était atteint d'un hypernéphrome métastatique. Cet essai a montré la non-infériorité du dénosumab par rapport à l'AZ en ce qui a trait à la réduction des événements osseux dans le groupe pris dans son ensemble; par contre, aucune analyse par sousgroupes portant sur les patients atteints d'hypernéphrome n'a été menée 48 . À la lumière de ces données, on peut aussi considérer comme une option raisonnable le recours au dénosumab dans cette population de patients.…”

Section: Rôle De La Radiothérapieunclassified

Prise en charge du cancer du rein de stade avancé : Mise à jour 2013 des lignes directrices consensuelles du Forum canadien sur le cancer du rein

North¹

2013

CUAJ

View full text Add to dashboard Cite

Randomized, Double-Blind Study of Denosumab Versus Zoledronic Acid in the Treatment of Bone Metastases in Patients With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma

Cited by 1,081 publications

References 36 publications

Surgery Combined with LPRF in Denosumab Osteonecrosis of the Jaw: Case Report

Surgery Combined with LPRF in Denosumab Osteonecrosis of the Jaw: Case Report

Postmenopausal osteoporosis treatment with antiresorptives: Effects of discontinuation or long-term continuation on bone turnover and fracture risk—a perspective

Prise en charge du cancer du rein de stade avancé : Mise à jour 2013 des lignes directrices consensuelles du Forum canadien sur le cancer du rein

Contact Info

Product

Resources

About