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When the bone drug Prolia (denosumab) first got here out in 2010, I took a tough have a look at it as a result of it used a very completely different mechanism than broadly used bisphosphonate medication, specializing in the RANK/RANK-L/OPG system to stop osteoclasts from being “activated” as an alternative of reducing their quantity like bisphosphonates. I wasn’t happy in 2010 that this drug was any safer or simpler than bisphosphonates, and unhappy to say my skepticism has been borne out by current analysis.
Dr. Brown’s 2024 Replace:
Is Prolia a blockbuster bone drug — or a bust?
The FREEDOM Trial, which studied Prolia use in postmenopausal girls for 3 years, discovered little or no discount in fracture threat. Vertebral and hip fractures had been diminished 4.8% and 0.3% — that means for 100 girls they handled, solely 5 noticed fewer vertebral fractures than you’d count on with a placebo, and not even one lady was spared from a hip fracture by the drug. Provided that hip fractures are significantly extra dangerous than vertebral fractures, these are minimal advantages certainly.
Though good points in bone density had been noticed, these good points had been misplaced inside 1 yr of halting the drug (Cummings et al., 2017).
Moreover, as soon as they stopped utilizing Prolia, sufferers’ threat of vertebral fracture rapidly (<1–2 years) reverted to the identical threat seen in those that’d by no means taken the drug within the first place (Cummings et al., 2017). In addition they misplaced a big quantity of the bone they’d gained by utilizing Prolia — 35.5% of the entire achieve within the backbone, 44.6% of the entire achieve within the femoral neck and 103.3% within the complete hip (Zanchetta et al., 2017). In different phrases, the drug provided no lasting profit.
Way more regarding: the discovering that sufferers had been extra inclined to having a number of vertebral fractures after discontinuing Prolia than sufferers who’d by no means taken the drug in any respect — and it was particularly excessive in those that’d had such fractures previous to happening the drug within the first place (Cummings et al., 2017; Anastasilakis et al., 2017). This discovering confirmed plenty of earlier case stories of “rebound fractures” in sufferers who had discontinued Prolia inside the previous 12 months. Researchers speculated such fractures had been a consequence of sudden renewal of bone resorption after the drug was stopped together with the absence of restore mechanisms throughout its use (Anastasilakis et al., 2017; Lamy et al., 2017; Polyzos & Terpos, 2016).
I’ve stated repeatedly that working towards nature invitations unintended penalties, so I’m not shocked by these outcomes. What’s disappointing is the continued emphasis on the “magic bullet” method to osteoporosis, when it has been clear for therefore a few years that Prolia simply doesn’t work.
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Anastasilakis AD, Polyzos SA, Makras P, Aubry-Rozier B, Kaouri S, Lamy O. Scientific options of 24 sufferers with rebound-associated vertebral fractures after denosumab discontinuation: systematic overview and extra circumstances. J Bone Miner Res. 2017 Jun; 32 (6): 1291-1296. DOI: 10.1002/JBMR.3110. EPUB 2017 Mar 13.
Cummings SR, Ferrari S, Eastell R, Gilchrist N, Jensen JB, McClung M, Roux C, Törring O, Valter I, Wang AT, Brown JP. Vertebral fractures after discontinuation of denosumab: a submit hoc evaluation of the randomized placebo-controlled FREEDOM Trial and its extension. J Bone Miner Res. 2017 Nov 4. doi: 10.1002/jbmr.3337. (Epub forward of print)
Lamy O, Gonzalez-Rodriguez E, Stoll D, Hans D, Aubry-Rozier B1. Extreme rebound-associated vertebral fractures after denosumab discontinuation: 9 medical circumstances report. J Clin Endocrinol Metab. 2017 Feb 1;102(2):354-358. doi: 10.1210/jc.2016-3170
Polyzos SA, Terpos E. Scientific vertebral fractures following denosumab discontinuation. Endocrine. 2016 Oct;54(1):271-272. Epub 2016 Jul 8.
Popp AW, Zysset PK, Lippuner Ok. Rebound-associated vertebral fractures after discontinuation of denosumab-from clinic and biomechanics. Osteoporosis Int. 2016 Might;27(5):1917-21. doi: 10.1007/s00198-015-3458-6. Epub 2015 Dec 22.
Zanchetta MB, Boailchuk J, Massari F, Silveira F, Bogado C, Zanchetta JR. Vital bone loss after stopping long-term denosumab remedy: a submit FREEDOM examine. Osteoporosis Int. 2018 Jan;29. doi: 10.1007/s00198-017-4242-6. (Epub forward of print)
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