Change in Bone Density and Reduction in Fracture Risk: A Meta-Regression of Published Trials

Bouxsein, Mary L.; Eastell, Richard; Lui, Li‐Yung; Liu, Wu; Papp, Anne E. de; Grauer, Andreas; Marin, Francísco; Cauley, Jane A.; Bauer, Douglas C.; Black, Dennis M.

doi:10.1002/jbmr.3641

Cited by 226 publications

(180 citation statements)

References 63 publications

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“…In addition to the likely long-term benefit, a prior study in human cadaveric femurs demonstrated that AGN1 implantation also leads to an immediate increase in femoral strength [18]. Although the sample size does not allow for a statistical assessment of fracture reduction, increased aBMD and femoral strength via FEA correlates with bone strength and fracture risk reduction [19,20,22,23], suggesting that AGN1 LOEP has the potential to reduce hip fracture risk.…”

Section: Discussionmentioning

confidence: 99%

“…There is ample evidence for a strong correlation between aBMD of the proximal femur and hip fracture risk [8,22]. For example, in the HORIZON Recurrent Fracture Trial, which tested whether zoledronic acid would prevent contralateral hip fractures in those who had already suffered one hip fracture, modest increases in femoral neck aBMD (3.6% over 3 years) led to a clinically meaningful and significant 30% decrease in the incidence of hip fractures [24].…”

Section: Discussionmentioning

confidence: 99%

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Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study

Howe¹,

Hill²,

Stroncek³

et al. 2019

Osteoporos Int

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This first-inhuman study of AGN1 LOEP demonstrated that this minimally-invasive treatment durably increased aBMD in femurs of osteoporotic postmenopausal women. AGN1 resorption was coupled with new bone formation by 12 weeks and that new bone was maintained for at least 5-7 years resulting in substantially increased FEA-estimated femoral strength. Introduction This first-inhuman study evaluated feasibility, safety, and in vivo response to treating proximal femurs of postmenopausal osteoporotic women with a minimally-invasive local osteo-enhancement procedure (LOEP) to inject a resorbable triphasic osteoconductive implant material (AGN1). Methods This prospective cohort study enrolled 12 postmenopausal osteoporotic (femoral neck T-score ≤ − 2.5) women aged 56 to 89 years. AGN1 LOEP was performed on left femurs; right femurs were untreated controls. Subjects were followed-up for 5-7 years. Outcomes included adverse events, proximal femur areal bone mineral density (aBMD), AGN1 resorption, and replacement with bone by X-ray and CT, and finite element analysis (FEA) estimated hip strength. Results Baseline treated and control femoral neck aBMD was equivalent. Treated femoral neck aBMD increased by 68 ± 22%, 59 ± 24%, and 58 ± 27% over control at 12 and 24 weeks and 5-7 years, respectively (p < 0.001, all time points). Using conservative assumptions, FEA-estimated femoral strength increased by 41%, 37%, and 22% at 12 and 24 weeks and 5-7 years, respectively (p < 0.01, all time points). Qualitative analysis of X-ray and CT scans demonstrated that AGN1 resorption and replacement with bone was nearly complete by 24 weeks. By 5-7 years, AGN1 appeared to be fully resorbed and replaced with bone integrated with surrounding trabecular and cortical bone. No procedure-or device-related serious adverse events (SAEs) occurred. Conclusions Treating femurs of postmenopausal osteoporotic women with AGN1 LOEP results in a rapid, durable increase in aBMD and femoral strength. These results support the use and further clinical study of this approach in osteoporotic patients at high risk of hip fracture.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study

Howe¹,

Hill²,

Stroncek³

et al. 2019

Osteoporos Int

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“…Age and BMD were closely related to the occurrence of neck shortening. With increasing age, BMD may decline, and it is clear that bone quality may determine the probability of femoral neck fracture [32]. Reduction of the axial anti-compression strength of the femoral neck leads to its shortening.…”

Section: Discussionmentioning

confidence: 99%

Analysis on risk factors for neck shortening after internal fixation for Pauwels II femoral neck fracture in young patients

Zhao

Guo

Wang

et al. 2020

Preprint

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Background: Femoral neck shortening can occur in young patients receiving closed reduction and internal fixation for Pauwels type II femoral neck fracture. The risk factors for neck shortening, which can affect hip function, are not clear. This study aimed to retrospectively identify risk factors for neck shortening after closed reduction and internal fixation with parallel partially threaded cannulated cancellous screws for Pauwels type II femoral neck fracture in young patients.Methods: Clinical data from 122 cases with Pauwels type II femoral neck fracture from February 2014 to February 2019 were reviewed and analyzed, and causes of neck shortening were statistically analyzed. These patients were followed (average follow-up: 12 months). And the chi-square test or t test was used to compare indicators. Multivariate analysis was conducted with non-conditional logistic regression analysis. Results: Statistically significant differences were found in age, sex, BMD, BMI, fracture type, posterior medial cortex comminution, and reduction quality between patients with femoral neck shortening and those without femoral neck shortening. Logistic regression analysis showed that fracture type, posterior medial cortex comminution, and reduction quality were the main risk factors for neck shortening. Conclusion：Fracture type, posterior medial cortex comminution, and reduction quality can be used as important reference indexes to predict the possibility of neck shortening after closed reduction and internal fixation with parallel, partially threaded, cannulated cancellous screws for Pauwels type II femoral neck fracture in young patients.BMD and BMI may be also risk factors.

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“…Group‐level clinical trial data suggest that larger BMD increases are associated with greater fracture risk reduction . A meta‐regression of published trials found that greater improvements in total hip, femoral neck, and lumbar spine BMD were strongly associated with greater reductions in vertebral fractures . In the clinical trials setting, there may be relatively little value in BMD monitoring because all patients are closely monitored for adherence and there is uniformity in the treatment regimen .…”

Section: Discussionmentioning

confidence: 99%

Association of Bone Density Monitoring in Routine Clinical Practice With Anti-Osteoporosis Medication Use and Incident Fractures: A Matched Cohort Study

Leslie

Morin

Martineau

et al. 2019

Journal of Bone and Mineral Research

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Routine bone mineral density (BMD) monitoring of individuals during the initial 5 years of anti-osteoporosis treatment is controversial. Using a registry-based cohort from the Province of Manitoba, Canada, we compared anti-osteoporosis medication use and fracture outcomes in women with versus without BMD monitoring receiving anti-osteoporosis medication. We identified 4559 women aged 40 years and older receiving anti-osteoporosis therapy with serial BMD testing (monitoring) within 5 years (mean interval 3.2 years) and 4559 propensity score-matched women without BMD monitoring. We assessed anti-osteoporosis medication use over 5 years from a population-based retail pharmacy database. Incident fractures to 10 years from health services data. During median 10 years observation, 1225 (13.4%) women developed major osteoporotic fracture, including 382 (4.2%) with hip fractures. Monitored women had significantly better fracture-free survival for major osteoporotic fracture (p = 0.040; 10-year cumulative risk 1.9% lower, 95% confidence interval [CI] 0.3-3.6%) and hip fracture (p = 0.001; 10-year cumulative risk 1.8% lower, 95% CI 0.7-2.8%) compared with women who were not monitored. Hazard ratios (HRs) were significantly lower in monitored versus not monitored women for major osteoporotic fracture (HR = 0.89, 95% CI 0.80-0.98) and hip fracture (HR = 0.74, 95% CI 0.63-0.87). Days of medication use, medication persistence ratio, and treatment switching over 5 years were greater in monitored versus not monitored women. At the end of 5 years, more women in the monitored group persisted on treatment and more switched treatment, with switching behavior associated with an observed interval reduction in BMD. In conclusion, our findings suggest a possible role for BMD monitoring after initiating anti-osteoporosis therapy in the routine clinical practice setting.

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Change in Bone Density and Reduction in Fracture Risk: A Meta-Regression of Published Trials

Cited by 226 publications

References 63 publications

Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study

Treatment of bone loss in proximal femurs of postmenopausal osteoporotic women with AGN1 local osteo-enhancement procedure (LOEP) increases hip bone mineral density and hip strength: a long-term prospective cohort study

Analysis on risk factors for neck shortening after internal fixation for Pauwels II femoral neck fracture in young patients

Association of Bone Density Monitoring in Routine Clinical Practice With Anti-Osteoporosis Medication Use and Incident Fractures: A Matched Cohort Study

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