AGN1 implant material to treat bone loss: Resorbable implant forms normal bone with and without alendronate in a canine critical size humeral defect model

Shaul, Jonathan L.; Hill, Ronald S.; Bouxsein, Mary L.; Burr, David B.; Tilton, Annemarie K.; Howe, James G.

doi:10.1016/j.bone.2021.116246

Cited by 5 publications

(5 citation statements)

References 24 publications

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“…New bone formation as the implant resorbs was demonstrated for AGN1 using histology in preclinical studies, correlating with changes in biomechanical properties. ( 9 ) Although clinical testing has shown apparent resorption and bone formation paired with increases in BMD after injection in postmenopausal osteoporotic women, ( 1 ) confirmatory clinical histology and biomechanical testing has not been possible to date. Therefore, development of new and clinically applicable techniques to distinguish calcium‐based implant materials from native bone would improve the evaluation of the effectiveness of such materials to replace osteoporotic bone loss.…”

Section: Discussionmentioning

confidence: 99%

“…(7) In preclinical models, both microCT and histopathology demonstrated resorption and replacement of the implant material with bone. (8,9) However, similar resorption and replacement shown during clinical evaluation (1) relied solely on imaging techniques and has not been confirmed using histopathology. In the absence of histopathology, the separation of resorbable implant materials and bone remains challenging with standard imaging techniques.…”

Section: Background Of the Studymentioning

confidence: 99%

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Dual-Layer Spectral–Computed Tomography Enhances the Separability of Calcium-Based Implant Material from Bone: An Ex Vivo Quantitative Imaging Study

Peña

Shaul²,

Müller

et al. 2020

Journal of Bone and Mineral Research

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Local treatment of bone loss with an injection of a resorbable, calcium-based implant material to replace bone has a long history of clinical use. The in vivo discrimination of changes in bone versus implant is challenging with standard computed tomography (CT). However, spectral-CT techniques enable the separation between tissues of similar densities but different chemical compositions. Dual-layer spectral-CT imaging and postprocessing analysis methods were applied to investigate the separability of AGN1 (a triphasic calcium-based implant) and bone after AGN1 injection in n = 10 male cadaveric femurs ex vivo. Using the area under the curve (AUC) from receiver-operating characteristic (ROC) analyses, the separability of AGN1 from bone was assessed for AGN1 (postoperatively) versus compact and versus femoral neck cancellous bone (both preoperatively). CT techniques included conventional Hounsfield (HU) and density-equivalent units (BMD, mg hydroxyapatite [HA]/cm 3 ) and spectral-CT measures of effective atomic number (Zeff ) and electron density (ED). The samples had a wide range of femoral neck BMD (55.66 to 241.71 mg HA/cm 3 ). At the injection site average BMD, HU, Zeff, and ED increased from 69.5 mg HA/cm 3 , 109 HU, 104.38 EDW, and 8.30 Zeff in the preoperative to 1233 mg HA/cm 3 , 1741 HU, 181.27 EDW, and 13.55 Zeff in the postoperative CT scan, respectively. For compact bone at the femoral shaft the preoperative values were 1124.15 mg HA/cm 3 , 1648 HU, 177 EDW, and 13.06 Zeff and were maintained postoperatively. Zeff showed substantially sharper distributions and significantly greater separability compared to ED, BMD, and HU (all p < 0.002, for both regions) with average AUCs for BMD, HU, ED, and Zeff of 0.670, 0.640, 0.645, and 0.753 for AGN1 versus compact and 0.996, 0.995, 0.994, and 0.998 for AGN1 versus femoral neck cancellous sites, respectively. Spectral-CT permits better discrimination of calciumbased implants like AGN1 from bone ex vivo. Our results warrant application of spectral-CT in patients undergoing procedures with similar implants.

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Section: Discussionmentioning

confidence: 99%

Section: Background Of the Studymentioning

confidence: 99%

Dual-Layer Spectral–Computed Tomography Enhances the Separability of Calcium-Based Implant Material from Bone: An Ex Vivo Quantitative Imaging Study

Peña

Shaul²,

Müller

et al. 2020

Journal of Bone and Mineral Research

Self Cite

View full text Add to dashboard Cite

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“…Femoral strength was significantly higher in the treated femur compared with the control contralateral one at 12 weeks, 24 weeks, and 5-7 years (36% greater) following the LOEP procedure. No procedure or device-related serious adverse events have been recorded [41][42][43] .…”

Section: Agn1 Osteo-enhancementmentioning

confidence: 99%

Addressing local bone loss in the proximal femurs of women at high risk of fracture

Paracuollo

Pellegrino

Santulli

et al. 2022

International Journal of Bone Fragility

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Proximal femoral fractures in older women are a worldwide leading cause of morbidity and mortality and a public health problem. Although pharmacological therapies can improve bone mineral density (BMD) and reduce fracture risk, current efforts are focused on researching a procedure that guarantees both immediate and long-lasting effectiveness over time. The AGN1 local osteo-enhancement procedure is a recently developed bone augmentation procedure. This minimally-invasive surgical approach is used to prepare an enhancement site, the area where new bone is desired within a local bony region weakened by osteoporotic bone loss, and fill it with a triphasic, resorbable, calcium-based implant material. This procedure results in a notable, statistically significant and sustained long-term increase in proximal femur BMD and femoral strength, improving femoral neck resistance to compression and distraction forces acting on it and thereby preventing fall-related fractures.

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“…Local osteo-enhancement procedure (LOEP) is an emerging surgical procedure that has been shown to effectively reduce the risk of re-fracture. 89 In synthesis, LOEP involves the implantation of an osteoconductive, calcium-based, material in the skeleton. The implant is rapidly incorporated and gives biomechanical benefit.…”

Section: Future Perspective On Osteoporosis Therapiesmentioning

confidence: 99%

“… 90 To date, LOEPs have been performed at femurs and vertebrae but, virtually, such procedures can be performed at any site. 89 , 91 In 2020, a long-term prospective cohort study on LOEP was published. 92 The authors treated 12 postmenopausal osteoporotic women with femoral LOEP and found that treated femoral neck BMD rapidly increased by 68% as soon as 3 months of follow-up.…”

Section: Future Perspective On Osteoporosis Therapiesmentioning

confidence: 99%

Osteoporosis in 10 years time: a glimpse into the future of osteoporosis

Adami

Fassio

Gatti

et al. 2022

Therapeutic Advances in Musculoskeletal

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Patients living with osteoporosis are projected to increase dramatically in the next decade. Alongside the forecasted increased societal and economic burden, we will live a crisis of fractures. However, we will have novel pharmacological treatment to face this crisis and, more importantly, new optimized treatment strategies. Fracture liaison services will be probably implemented on a large scale worldwide, helping to prevent additional fractures in high-risk patients. In the next decade, novel advances in the diagnostic tools will be largely available. Moreover, new and more precise fracture risk assessment tools will change our ability to detect patients at high risk of fractures. Finally, big data and artificial intelligence will help us to move forward into the world of precision medicine. In the present review, we will discuss the future epidemiology and costs of osteoporosis, the advances in early and accurate diagnosis of osteoporosis, with a special focus on biomarkers and imaging tools. Then we will examine new and refined fracture risk assessment tools, the role of fracture liaison services, and a future perspective on osteoporosis treatment.

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AGN1 implant material to treat bone loss: Resorbable implant forms normal bone with and without alendronate in a canine critical size humeral defect model

Cited by 5 publications

References 24 publications

Dual-Layer Spectral–Computed Tomography Enhances the Separability of Calcium-Based Implant Material from Bone: An Ex Vivo Quantitative Imaging Study

Dual-Layer Spectral–Computed Tomography Enhances the Separability of Calcium-Based Implant Material from Bone: An Ex Vivo Quantitative Imaging Study

Addressing local bone loss in the proximal femurs of women at high risk of fracture

Osteoporosis in 10 years time: a glimpse into the future of osteoporosis

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