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Effect of bisphosphonates or teriparatide on mechanical complications after posterior instrumented fusion for osteoporotic vertebral fracture: a multi-center retrospective study.

ABSTRACT: BACKGROUND:The optimal treatment of osteoporosis after reconstruction surgery for osteoporotic vertebral fractures (OVF) remains unclear. In this multicentre retrospective study, we investigated the effects of typically used agents for osteoporosis, namely, bisphosphonates (BP) and teriparatide (TP), on surgical results in patients with osteoporotic vertebral fractures. METHODS:Retrospectively registered data were collected from 27 universities and affiliated hospitals in Japan. We compared the effects of BP vs TP on postoperative mechanical complication rates, implant-related reoperation rates, and clinical outcomes in patients who underwent posterior instrumented fusion for OVF. Data were analysed according to whether the osteoporosis was primary or glucocorticoid-induced. RESULTS:A total of 159 patients who underwent posterior instrumented fusion for OVF were included. The overall mechanical complication rate was significantly lower in the TP group than in the BP group (BP vs TP: 73.1% vs 58.2%, p =?0.045). The screw backout rate was significantly lower and the rates of new vertebral fractures and pseudoarthrosis tended to be lower in the TP group than in the BP group. However, there were no significant differences in lumbar functional scores and visual analogue scale pain scores or in implant-related reoperation rates between the two groups. The incidence of pseudoarthrosis was significantly higher in patients with glucocorticoid-induced osteoporosis (GIOP) than in those with primary osteoporosis; however, the pseudoarthrosis rate was reduced by using TP. The use of TP also tended to reduce the overall mechanical complication rate in both primary osteoporosis and GIOP. CONCLUSIONS:The overall mechanical complication rate was lower in patients who received TP than in those who received a BP postoperatively, regardless of type of osteoporosis. The incidence of pseudoarthrosis was significantly higher in patients with GIOP, but the use of TP reduced the rate of pseudoarthrosis in GIOP patients. The use of TP was effective to reduce postoperative complications for OVF patients treated with posterior fusion.

SUBMITTER: Kawabata A

PROVIDER: S-EPMC7331246 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Effect of bisphosphonates or teriparatide on mechanical complications after posterior instrumented fusion for osteoporotic vertebral fracture: a multi-center retrospective study.

Kawabata Atsuyuki A Yoshii Toshitaka T Hirai Takashi T Ushio Shuta S Kaito Takashi T Yamashita Tomoya T Fujiwara Hiroyasu H Nagamoto Yukitaka Y Matsuoka Yuji Y Suzuki Hidekazu H Nishimura Hirosuke H Terai Hidetomi H Tamai Koji K Tagami Atsushi A Yamada Syuta S Adachi Shinji S Watanabe Kei K Katsumi Keiichi K Ohashi Masayuki M Shibuya Yohei Y Harimaya Katsumi K Kawaguchi Kenichi K Yokoyama Nobuhiko N Oishi Hidekazu H Doi Toshiro T Kimura Atsushi A Inoue Hirokazu H Inoue Gen G Miyagi Masayuki M Saito Wataru W Nakano Atsushi A Sakai Daisuke D Nukaga Tadashi T Ikegami Shota S Shimizu Masayuki M Futatsugi Toshimasa T Ohtori Seiji S Furuya Takeo T Orita Sumihisa S Imagama Shiro S Ando Kei K Kobayashi Kazuyoshi K Kiyasu Katsuhito K Murakami Hideki H Yoshioka Katsuhito K Seki Shoji S Hongo Michio M Kakutani Kenichiro K Yurube Takashi T Aoki Yasuchika Y Oshima Masashi M Takahata Masahiko M Iwata Akira A Endo Hirooki H Abe Tetsuya T Tsukanishi Toshinori T Nakanishi Kazuyoshi K Watanabe Kota K Hikata Tomohiro T Suzuki Satoshi S Isogai Norihiro N Okada Eijiro E Funao Haruki H Ueda Seiji S Shiono Yuta Y Nojiri Kenya K Hosogane Naobumi N Ishii Ken K

BMC musculoskeletal disorders 20200701 1

<h4>Background</h4>The optimal treatment of osteoporosis after reconstruction surgery for osteoporotic vertebral fractures (OVF) remains unclear. In this multicentre retrospective study, we investigated the effects of typically used agents for osteoporosis, namely, bisphosphonates (BP) and teriparatide (TP), on surgical results in patients with osteoporotic vertebral fractures.<h4>Methods</h4>Retrospectively registered data were collected from 27 universities and affiliated hospitals in Japan. W ...[more]

PMID: 32611386

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Project description:UNLABELLED:Daily teriparatide injections have been shown to reduce vertebral and non-vertebral fractures. Here, we demonstrate that the magnitude of fracture risk reduction is independent of baseline fracture probability assessed by FRAX. INTRODUCTION:Daily administration of 20 or 40 ?g teriparatide has been shown to significantly decrease the risk of vertebral and non-vertebral fracture compared with placebo. The aim of the present study was to evaluate fracture risk assessed at baseline using the FRAX® tool and to determine the efficacy of teriparatide as a function of baseline fracture risk. METHODS:One thousand six hundred thirty-seven postmenopausal women in the pivotal phase three trial, randomly assigned to receive placebo (n?=?544), teriparatide 20 ?g per day (n?=?541) or teriparatide 40 ?g per day (n?=?552), were studied. Baseline clinical risk factors were entered into country-specific FRAX models to compute the 10-year probability of major osteoporotic fractures with or without input of femoral neck BMD. Because there was no difference in effect of 20 and 40 ?g teriparatide daily on fracture occurrence, the two active groups were merged. The interaction between probability of a major fracture and treatment efficacy was examined by Poisson regression. RESULTS:The 10-year probability of major osteoporotic fractures (with BMD) ranged from 2.2-67.2 %. Treatment with teriparatide was associated with a 37 % decrease in all non-vertebral fractures (95 % CI 10-56 %) and a 56 % decrease in low-energy non-vertebral fractures (95 % CI 24-75 %) compared with placebo. The risk of morphometric vertebral fractures decreased significantly by 66 % (95 % CI 50-77 %). Hazard ratios for the effect of teriparatide on the fracture outcome did not change significantly with increasing fracture probability (p?>?0.30). Similar findings were noted for the interaction when BMD was excluded from the FRAX model, or when probability of hip fracture was used as the marker of baseline risk. CONCLUSION:We conclude that teriparatide significantly decreases the risk of non-vertebral and morphometric vertebral fractures in women by a similar extent, irrespective of baseline fracture probability.

Project description:Using a Markov microsimulation model among hypothetical cohorts of community-dwelling older osteoporotic Japanese women with prior vertebral fracture over a lifetime horizon, we found that daily subcutaneous teriparatide for 2 years followed by weekly oral alendronate for 8 years was not cost-effective compared with alendronate monotherapy for 10 years.PurposeTeriparatide has proven efficacy in reducing osteoporotic fractures, but with substantial cost. We examined the cost-effectiveness of sequential teriparatide/alendronate (i.e., daily subcutaneous teriparatide for 2 years followed by weekly oral alendronate for 8 years) compared with alendronate monotherapy for 10 years among community-dwelling older osteoporotic women with prior clinical or morphometric vertebral fracture in Japan.MethodsUsing a previously validated and updated Markov microsimulation model, we obtained incremental cost-effectiveness ratios (Japanese yen [¥] (or US dollars [$]) per quality-adjusted life year [QALY]) from the perspective of a single payer responsible for both public healthcare and long-term care. We assumed a lifetime horizon with a willingness-to-pay of ¥5million (or $47,500) per QALY in the base case. We modeled the cost of biosimilar teriparatide, which has been available since November 2019 in Japan, assuming the efficacy was the same as that of the brand version.ResultsIn the base case, sequential teriparatide/alendronate was not cost-effective compared with alendronate monotherapy. In deterministic sensitivity analyses, sequential teriparatide/alendronate would become cost-effective with 85%, 50%, and 15% price discounts to teriparatide at ages 70, 75, and 80, respectively, compared to the current biosimilar cost. Otherwise, results were especially sensitive to changes that affected efficacy of teriparatide or alendronate. In probabilistic sensitivity analyses, the probabilities of sequential teriparatide/alendronate being cost-effective were 0%, 1%, and 37% at ages 70, 75, and 80, respectively.ConclusionsAmong high-risk osteoporotic women in Japan, sequential teriparatide/alendronate was not cost-effective compared with alendronate monotherapy, even with the availability of biosimilar teriparatide.

Project description:Background contextOsteoporotic vertebral fractures (OVFs) can lead to severe pain and reduced function and quality-of-life, but the strength of evidence for treatments remains low, particularly in younger populations.PurposeTo determine whether patients with OVFs who received kyphoplasty had different patterns of healthcare utilization compared to propensity-matched patients who did not receive vertebral augmentation.DesignObservational cohort study.Patient sampleWe identified patients with OVFs from 2007 to 2018 in the IBM MarketScan Commercial Claims and Encounters Databases who received kyphoplasty and compared them to propensity-matched controls who did not receive vertebral augmentation (either kyphoplasty or vertebroplasty).Outcome measuresMajor medical complications within 30 days, fills of opioids from 1-week through 1-month postaugmentation, and spine-related gross covered payments from 3-days postkyphoplasty through 1-year post-OVF.MethodsWe used logistic regression to obtain odds ratios (ORs) and 95% confidence intervals (95% CIs) to compare binary outcomes and median analysis to compare continuous outcomes.ResultsOf the 15,197 OVF patients identified, 1,969 (13%) received kyphoplasty and 1,928 (98%) of these were propensity matched to nonaugmented controls. We did not observe differences in the odds of major medical complications within 30 days (adjusted OR [95% CI]: 1.0 [0.6, 1.8]) but patients who received kyphoplasty were more likely to have filled opioid medications within 30 days (adjusted OR [95% CI]: 1.3 [1.1, 1.5]) and had greater spine-related gross covered payments (kyphoplasty median [95% CI]: $1,340 [$240, $4,850]; nonaugmented: $7,870 [$7,480, $8,270]; adjusted difference in medians [95% CI]: $260 [$190, $2,050]).ConclusionsIn this cohort of patients <65 years, receipt of kyphoplasty was associated with greater likelihood of opioid fills and somewhat greater spine-related gross covered payments, but no difference in major medical complications. In this retrospective study of administrative data, we did not detect advantages of treatment with kyphoplasty compared with nonaugmentation for any of our outcomes.

Project description:ObjectiveTeriparatide has been increasingly utilized in the management of osteoporosis. The efficacy of low and high dose teriparatide on lumbar spine bone mineral density, vertebral fracture incidence and pain is unknown. We sought to determine the efficacy of teriparatide on these patient-important outcomes using a systematic review and meta-analysis.MethodsA systematic search of electronic databases (MEDLINE, EMBASE, CENTRAL, CINAHL) was performed to identify randomized controlled trials (RCTs) that evaluate teriparatide to any comparator for the treatment of osteoporosis in postmenopausal women. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria were used by two independent reviewers to assess the strength and quality of evidence.ResultsA total of 20 studies (n = 6024) were included in this review, with 2855 patients receiving teriparatide and 3169 patients receiving placebo or control treatment. A teriparatide dose of 20 μg/day increased lumbar spine bone mineral density (BMD) (standardized mean difference (SMD) 0.34 standard deviation (SD) units higher (95% CI 0.19-0.48 SDs higher) in comparison to placebo. Relative to anti-resorptive agents, 20 μg/day of teriparatide had a range from 0.14 SD units to 0.96 SD units higher (95% CI, 0.08 SDs lower to 0.36 SDs higher, CI, 0.33-1.59 SDs higher, respectively). 20 μg/day teriparatide had a significant effect on pain severity to placebo or control (SMD 0.80, 95% CI, 1.16-0.43 SDs lower) and also decreased the incidence of vertebral fractures compared to placebo (relative risk 0.31, 95% CI 0.21 to 0.46). Arthralgia and extremity pain incidence were also calculated; there were 15 and 8 fewer events per 1000 patients with the use of 20 μg/day of teriparatide compared to placebo or control, respectively.ConclusionHigh quality evidence supports the utilization of teriparatide 20 μg/day dose to significantly improve lumbar spine BMD and decrease incidence of vertebral fractures and pain severity relative to all comparators. 40 μg/day dose of teriparatide demonstrated significantly better results with prolonged treatment. This data is valuable for clinicians involved in the care of this growing demographic of patients. Further investigation on the safety and efficacy of teriparatide in higher doses for the long-term treatment of osteoporosis in postmenopausal women should be conducted through high-quality clinical trials.

Dataset Information

Effect of bisphosphonates or teriparatide on mechanical complications after posterior instrumented fusion for osteoporotic vertebral fracture: a multi-center retrospective study.

Publications

Effect of bisphosphonates or teriparatide on mechanical complications after posterior instrumented fusion for osteoporotic vertebral fracture: a multi-center retrospective study.

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