Denosumab Prevents Early Periprosthetic Bone Loss After Uncemented Total Hip Arthroplasty: Results from a Randomized Placebo-Controlled Clinical Trial

Nyström, Andreas; Kiritopoulos, Demostenis; Ullmark, Gösta; Sørensen, Jens Ahm; Petrén-Mallmin, Marianne; Milbrink, Jan; Hailer, Nils P; Mallmin, Hans

doi:10.1002/jbmr.3883

Cited by 33 publications

(56 citation statements)

References 39 publications

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“…(9)(10)(11) The current limited data demonstrated that denosumab is at least as effective as bisphosphonates in decreasing bone resorption, and denosumab even increases bone mass in some Gruen zones, although the exact BMD changes in each Gruen zone were not given in detail in the present study. (1,2) However, both studies found that the periprosthetic BMDs of the denosumab group approached the levels of the placebo group after discontinuation of denosumab, although the rebound effect was only observed in the present study and might have been missed in the other study. (1,2) The rapid reversal after cessation of denosumab has been well documented in previous research, and bisphosphonates are recommended to prevent the subsequent rebound increase in bone resorption, which was confirmed to be valid in a recent study.…”

Section: College Beijing Chinacontrasting

confidence: 56%

“…(1,2) However, both studies found that the periprosthetic BMDs of the denosumab group approached the levels of the placebo group after discontinuation of denosumab, although the rebound effect was only observed in the present study and might have been missed in the other study. (1,2) The rapid reversal after cessation of denosumab has been well documented in previous research, and bisphosphonates are recommended to prevent the subsequent rebound increase in bone resorption, which was confirmed to be valid in a recent study. (12)(13)(14)(15) Based on the current available evidence and the theoretical considerations of the pharmacodynamics of denosumab (as well as of bisphosphonates), at least two injections of denosumab every 6 months after THA should be used for preventing the rapid decreases of periprosthetic BMD within the first year.…”

Section: College Beijing Chinacontrasting

confidence: 56%

“…We read the recent study by Nyström and colleagues with great interest. (1) Using a prospective, randomized, double-blind, placebo-controlled design, they investigated whether denosumab could inhibit early periprosthetic bone loss after cementless total hip arthroplasty (THA). The results demonstrated that although denosumab is potently effective in preventing early periprosthetic bone loss after cementless THA, the effect diminishes and is even associated with rebound phenomenon after discontinuing treatment.…”

Section: College Beijing Chinamentioning

confidence: 99%

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The Efficacy of Denosumab for Prevention of Early Periprosthetic Bone Loss After Cementless Total Hip Arthroplasty

Shao

2020

Journal of Bone and Mineral Research

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Section: College Beijing Chinacontrasting

confidence: 56%

Section: College Beijing Chinacontrasting

confidence: 56%

Section: College Beijing Chinamentioning

confidence: 99%

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The Efficacy of Denosumab for Prevention of Early Periprosthetic Bone Loss After Cementless Total Hip Arthroplasty

Shao

2020

Journal of Bone and Mineral Research

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“…Over 500,000 THAs were performed in the USA annually, and the demand for THA is still growing [1].As one of the major concerns after THA, periprosthetic bone loss was closely related to aseptic loosening, periprosthetic fractures, and implant failure [2].It was reported that the mean periprosthetic bone loss was up to 21.9% 10 years post-operation [3,4]. Thus, medical intervention of periprosthetic bone loss in the immediate postoperative period was widely accepted [5,6]. However, not all the patients experienced periprosthetic bone loss after THA, especially those without osteopenia and osteoporosis [7,8].Correspondingly, identi cation of patients with increasedrisk of postoperative periprosthetic bone loss is of great value for clinical decision-makingand cost-effectiveness analysis on a patient-speci c level.…”

Section: Introductionmentioning

confidence: 99%

Perioperative Patient-specific Factors-based Nomograms Predict Short-term Periprosthetic Bone Loss After Total Hip Arthroplasty

Xue

et al. 2020

Preprint

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Background Although medical intervention of periprosthetic bone loss in the immediate postoperative period was recommended, not all the patients experienced periprosthetic bone loss after total hip arthroplasty (THA). Prediction toolsthat enrolledallpotential risk factors to calculate an individualized prediction of postoperative periprosthetic bone loss were strongly needed for clinical decision-making.MethodsData of the patients underwent primary unilateral cementless THA between April 2015 and October 2017 in our center were retrospectively collected. Candidate variables included demographic data and bone mineral density (BMD) in spine, hip and periprosthetic regions that measured 1 week after THA. Outcomes of interest included the risk of postoperative periprosthetic bone loss in Gruen zone 1, 7 and total zones in the 1st postoperative year. Nomograms were presented based on multiple logistic regressions via R language.Bootstrap was used for internal validation. Results 427 patients (195 male and 232 female) were included in this study.The mean BMD of Gruen zone 1, 7,and total were decreased by 4.1%, 6.4%, and 1.7% at the 1st year after THA, respectively. 61.1% of the patients (261/427) experienced bone loss in Gruen zone 1 at the 1st postoperative year, while there were 58.1% (248/427) in Gruen zone 7 and 63.0% (269/427) in Gruen zone total. Bias-corrected c-index for risk of postoperative bone lossin Gruen zone 1, 7 and total zones in the 1st postoperative year were 0.700, 0.785, and 0.696, respectively. The most highly influential factor for the postoperative periprosthetic bone loss was the BMD in the corresponding Gruen zones at the baseline.ConclusionsThe present study presented the perioperative factors-based nomograms for predicting periprosthetic bone loss after THA with adequate predictive discrimination and calibration.Those tools would helpsurgeons to identify high-risk patients who may benefit from anti-bone-resorptive treatment on the early postoperative period effectively. Such prediction model could also provide patients with reasonable expectations following surgery, which may improve satisfaction and patient compliance.

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In Reply to the Letter to the Editor: The Efficacy of Denosumab for Prevention of Early Periprosthetic Bone Loss After Cementless Total Hip Arthroplasty

Nyström

Hailer

Mallmin

2020

Journal of Bone and Mineral Research

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We appreciate the comments by Shao and Wu and the opportunity to discuss the effect of denosumab on periprosthetic bone after joint replacement surgery.Shao and Wu raise three questions regarding our recent article (1) in JBMR:1What is the external validity of our study? Can our results be generalized to an older population with a higher incidence of osteoporosis? 2Should patients undergoing uncemented total hip arthroplasty (THA) be treated with denosumab during the first year after surgery? 3Should anti-osteoporotic treatment be continued with bisphosphonates after withdrawal of denosumab?Regarding question 1: The external validity of our results is limited by the fact that most patients with osteoarthritis of the hip are around the age of 65 years. Those patients, however, usually receive cemented stems, and the explicit goal of our study was to investigate bone loss around uncemented stems used in THA. In a study by Aro and colleagues, (2) female patients (mean age 69 years) with osteoarthritis of the hip who were scheduled for uncemented THA were randomized to either denosumab or placebo. As pointed out by Shao and Wu, the magnitude of the effect of denosumab on bone mineral density (BMD) in both Gruen zone 7 and zones 1-7 was lower than in our study. A difference in the exact figures between these studies could be expected, but conclusions are hard to draw because both the type of implant that was investigated (CFP versus Accolade) and the type of technologies for the DXA scanners used (GE-Lunar versus Hologic) differed between the two studies. In addition, the study by Aro and colleagues included only women, whereas our study included almost 30% men. However, in accordance with our results, there was a substantial protective effect of denosumab on periprosthetic BMD measured after 12 months. (2) In two random-controlled trials (RCTs), one on osteopenic (mean age 59 years) and one on osteoporotic (mean age 72 years) women, randomized to either denosumab or placebo, there was a substantial positive effect of denosumab on BMD. At 12 months, BMD increased by 4% in the lumbar spine and 2.5% in the total hip in the cohort of younger patients, and in the cohort of older patients, BMD increased by 5% in the lumbar spine and by 3% in the total hip. (3,4) We conclude that loss of periprosthetic BMD in patients with osteoarthritis of the hip operated with an uncemented THA can be prevented by two doses of denosumab during the first year after surgery, and, given the evidence cited above, it is furthermore likely that the effect size of denosumab treatment is at least similar or even larger in older patients with reduced BMD.Regarding questions 2 and 3: The last two concerns are related to the question of whether prolonged treatment with denosumab or whether switching to other anti-osteoporotic agents such as bisphosphonates could sustain the effect of denosumab on periprosthetic BMD even after its discontinuation. Our study was not designed to answer these questions, and we believe that any recommendation on denosuma...

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Denosumab Prevents Early Periprosthetic Bone Loss After Uncemented Total Hip Arthroplasty: Results from a Randomized Placebo-Controlled Clinical Trial

Cited by 33 publications

References 39 publications

The Efficacy of Denosumab for Prevention of Early Periprosthetic Bone Loss After Cementless Total Hip Arthroplasty

The Efficacy of Denosumab for Prevention of Early Periprosthetic Bone Loss After Cementless Total Hip Arthroplasty

Perioperative Patient-specific Factors-based Nomograms Predict Short-term Periprosthetic Bone Loss After Total Hip Arthroplasty

In Reply to the Letter to the Editor: The Efficacy of Denosumab for Prevention of Early Periprosthetic Bone Loss After Cementless Total Hip Arthroplasty

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