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Frontiers in Biomaterials Science ·

Volume 5 - 2026 | https://doi.org/10.3389/fbiom.2026.1937864

3D- and 4D-printed scaffolds for osteoporotic bone regeneration: translational insights from in vivo preclinical and human-oriented studies

  • Miguel Castro-Rodríguez1
  • Luis Diaz-Gomez1
  • Yolanda Sanz2
  • Carmen Alvarez-Lorenzo1*corresponding author
  • María Vallet-Regí3*corresponding author
  1. 1Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Instituto de Materiales (iMATUS) and Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, Santiago de Compostela, Spain
  2. 2Microbiome Innovation in Nutrition and Health Research Unit (INNOBIOME), Institute of Agrochemistry and Food Technology, Spanish National Research Council (IATA-CSIC), Paterna, Spain
  3. 3Department of Chemistry in Pharmaceutical Sciences, School of Pharmacy, Institute Hospital 12 de Octubre (Imas 12), Universidad Complutense de Madrid (UCM), Madrid, Spain
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Abstract

Osteoporosis compromises bone repair through reduced osteogenic capacity, excessive osteoclast activity, oxidative stress, inflammation, impaired angiogenesis, and poor implant fixation. Three-dimensional printing has emerged as a powerful strategy to generate patient-specific scaffolds and implants with controlled porosity, mechanical properties, and bioactive interfaces. In osteoporotic bone, however, passive structural support is often insufficient, prompting the development of drug-loaded, immunomodulatory, antioxidant, osteoanabolic, and stimuli-responsive systems. This mini-review summarizes recent evidence on 3D- and 4D-printed scaffolds for osteoporosis, with emphasis on in vivo preclinical studies and human-oriented translational data. Current studies show that 3D-printed titanium, tantalum, magnesium alloy, calcium phosphate, bioactive glass, polycaprolactone (PCL), polylactic acid (PLA), polyetheretherketone (PEEK), and hybrid hydrogel-integrated scaffolds can enhance osseointegration and bone regeneration in osteoporotic animal models. Functional strategies include local delivery of simvastatin, zoledronic acid, alendronate, teriparatide, bone morphogenic proteins, platelet-rich plasma, strontium, magnesium, lanthanum, cerium, icaritin, and antioxidant or immunomodulatory agents. Emerging 4D-like systems introduce responsiveness to pH, reactive oxygen species (ROS), enzymes, temperature, magnetic fields, microcurrent, or near-infrared irradiation, enabling sequential release, self-healing, photothermal activation, and microenvironment-adaptive repair. Despite strong preclinical progress, true human clinical evidence remains scarce, and most human-oriented work is limited to finite element modeling, patient-specific implant design, biomechanical testing, cadaveric studies, or imaging phantoms. Translation will require large-animal validation, standardized osteoporotic models, long-term safety data, regulatory alignment, and comparative studies against current clinical standards.

Keywords

1 Introduction

Osteoporosis represents a major global health challenge, affecting an estimated over 200 million people worldwide and contributing to more than 8.9 million fragility fractures annually, corresponding to one fracture every three seconds (International Osteoporosis Foundation, 2026; World Health Organization, 2026). The societal and economic burden is substantial, particularly in aging populations, with hip and vertebral fractures associated with increased morbidity, mortality, and long-term disability. In addition to fracture risk, osteoporosis significantly impairs bone healing capacity, leading to delayed union, non-union, and a higher incidence of implant failure following surgical fixation (Chandran et al., 2024).

Osteoporotic bone defects and fragility fractures remain difficult to treat because the local repair environment is biologically and mechanically compromised. Reduced bone marrow stromal cell function, increased osteoclast activity, oxidative stress, chronic inflammation, cellular senescence, and impaired angiogenesis collectively limit bone formation and increase the risk of implant loosening or fixation failure (Farr and Khosla, 2019). These alterations do not only delay healing but also compromise the integration and long-term stability of implanted devices.

Additive manufacturing offers a route to address these challenges by producing porous, anatomically adapted scaffolds with controlled pore architecture, stiffness, and surface topography. In recent studies, 3D-printed scaffolds have evolved from passive mechanical supports into multifunctional platforms capable of local drug delivery, immune regulation, oxidative stress modulation, and osteogenic stimulation (Bai et al., 2020; Ding et al., 2023; Zhang J. et al., 2025; Vallet-Regí et al., 2026).

The purpose of this mini-review is to summarize advances in 3D- and 4D-printed scaffolds for osteoporosis, with a specific focus on in vivo preclinical evidence (Supplementary Table S1) and human-oriented translational studies. Original research articles were identified through the Web of Science database using the search terms “osteoporo”, “print”, “scaffold”, and “in vivo”, while clinical trials were retrieved from ClinicalTrials.gov between May and July 2026. Particular attention is given to scaffold composition, biological function, animal models, osseointegration, bone regeneration, and the persistent gap between promising experimental outcomes and clinical implementation. The main material platforms, functional strategies, biological effects, and translational status of these systems are summarized in Figure 1.

Overview of the current landscape of 3D- and 4D-printed scaffolds for osteoporotic bone regeneration. The scheme summarizes the main scaffold materials, functionalization strategies, stimuli-responsive approaches, biological effects demonstrated in preclinical studies, current translational evidence, major challenges to clinical implementation, and the ultimate goal of achieving safe, effective, and patient-specific therapies for osteoporotic bone repair. Figure created by the authors with the assistance of ChatGPT (OpenAI).
Figure 1. Overview of the current landscape of 3D- and 4D-printed scaffolds for osteoporotic bone regeneration. The scheme summarizes the main scaffold materials, functionalization strategies, stimuli-responsive approaches, biological effects demonstrated in preclinical studies, current translational evidence, major challenges to clinical implementation, and the ultimate goal of achieving safe, effective, and patient-specific therapies for osteoporotic bone repair. Figure created by the authors with the assistance of ChatGPT (OpenAI).

2 Pathophysiological requirements for osteoporotic scaffold design

Scaffolds intended for osteoporotic bone repair must do more than fill a defect. They must compensate for impaired osteogenesis, excessive resorption, inflammation, oxidative stress, and weak fixation. Several studies therefore combine structural support with osteoinductive or antiresorptive agents. For example, zoledronic acid-loaded magnesium alloy scaffolds combined the osteogenic effects of biodegradable magnesium with local osteoclast inhibition, improving healing of osteoporotic bone defects in vivo (Ran et al., 2023; Supplementary Table S1, entry 1). Similarly, alendronate-functionalized composite scaffolds reduced local bone resorption and promoted bone formation in osteoporotic defects (Xia et al., 2026; Supplementary Table S1, entry 2).

Another major design target is immune and oxidative stress regulation. Osteoporotic defects often show persistent inflammation and accumulation of reactive oxygen species (ROS), both of which impair mesenchymal stem cell survival and differentiation. ROS-scavenging hydrogels integrated with 3D-printed titanium prostheses protected bone marrow stromal cells (BMSCs), promoted M2 macrophage polarization, suppressed inflammatory cytokines, and enhanced osteointegration in osteoporotic models (Ding et al., 2023; Supplementary Table S1, entry 3). Related approaches using MnO2-functionalized calcium phosphate scaffolds similarly attempted to restore the osteogenic microenvironment by reducing oxidative damage (Chen et al., 2026; Supplementary Table S1, entry 4).

3 Architectural components of 3D-printed scaffolds for osteoporotic bone regeneration

3.1 Metallic scaffolds and porous implant interfaces

3D-printed porous titanium and Ti-6Al-4V scaffolds are among the most widely studied platforms for osteoporotic osseointegration because they provide high mechanical strength, tunable porosity, and reduced stiffness compared with dense metal implants (Bondarenko et al., 2023; Supplementary Table S1, entry 5). The success of bone formation and osseointegration in osteoporotic bones have been shown to improve with systemic administration of psoralen through a positive immunomodulatory response (Ji et al., 2026; Supplementary Table S1, entry 6).

Alternatively, the pores can be filled or coated with a variety of cell-friendly hydrogels to offer better interface with the living tissue (Park et al., 2023; Supplementary Table S1, entry 7). In ovariectomized animal models, freeze-dried platelet-rich plasma (PRP) coatings on porous Ti-6Al-4V improved BMSC attachment, migration, proliferation, osteogenic differentiation, bone regeneration, and osseointegration, with freeze-dried PRP outperforming traditional PRP (Qiao et al., 2020; Supplementary Table S1, entry 8). Pulse electromagnetic field stimulation has also been combined with 3D-printed porous titanium scaffolds, enhancing osteogenic differentiation of osteoporosis-derived BMSCs in vitro and improving osseointegration in vivo (Ye et al., 2021; Supplementary Table S1, entry 9).

Surface and interface engineering are central to titanium scaffold performance in osteoporosis. Hydrogel-integrated 3D-printed titanium alloy prosthetic interfaces delivering rapamycin restored autophagy in osteoporosis-derived BMSCs, provided antibacterial activity against S. aureus, and improved osseointegration while inhibiting infection in vivo (Li et al., 2022; Supplementary Table S1, entry 10). A supramolecular hyaluronic acid-based hydrogel interface incorporating BMSCs and bone morphogenic protein-2 (BMP-2) into 3D-printed porous metal scaffolds provided sustained BMP-2 release and improved the metal–bone interface under osteoporotic conditions (Bai et al., 2020; Supplementary Table S1, entry 11).

Magnesium-coated porous Ti-6Al-4V implants, meanwhile, primarily inhibited peri-implant osteolysis rather than directly enhancing osteogenesis, suggesting a potentially useful antiresorptive role in osteoporotic implant settings (Du et al., 2019; Supplementary Table S1, entry 12).

Recent titanium designs have also incorporated biomimetic hierarchical structures. A marine sponge-inspired Ti-6Al-4V “cell climbing frame” used nested macro- and micropores to reduce elastic modulus, improve blood penetration, support cell adhesion, and recruit/rejuvenate autologous BMSCs through E7 peptides and exosomes. In osteoporotic rats, this scaffold accelerated bone repair, delayed surrounding bone loss, and promoted multi-stage osseointegration (Lei et al., 2025; Supplementary Table S1, entry 13).

Tantalum scaffolds are also promising because their spatial configuration can regulate osteogenic signaling (Wu et al., 2025; Supplementary Table S1, entry 14). A 3D-printed tantalum scaffold enhanced repair of osteoporotic defects by modulating the SDF-1α/CXCR4 signaling axis, suggesting that scaffold architecture itself may influence endogenous cell recruitment and molecular repair pathways.

3.2 Biodegradable metallic and ceramic scaffolds

Biodegradable magnesium alloy scaffolds are attractive for osteoporotic bone defects because magnesium degradation products may support osteogenesis, although degradation must be controlled. 3D-printed Mg-Nd-Zn-Zr scaffolds coated with zoledronic acid-loaded ceramic composite slowed degradation, promoted BMSC osteogenesis through Mg2+ release, and inhibited osteoclast formation through zoledronic acid release, overall improving defect healing in osteoporotic models (Ran et al., 2023; Supplementary Table S1, entry 1). 3D-printed porous Mg2+-containing akermanite scaffolds enhanced bone regeneration in aged rat cranial defects by alleviating stem cell senescence and promoting osteogenesis and angiogenesis via the exosomal miR-196a-5p/Hoxa7/MAPK signaling axis, highlighting Mg2+-mediated exosome modulation as a promising therapeutic strategy for bone repair in osteoporotic bone (Qi et al., 2023; Supplementary Table S1, entry 15).

Calcium phosphate and bioactive ceramic scaffolds provide osteoconductive matrices with potential for ion release and local drug delivery. Lanthanum-doped octacalcium phosphate/PLA scaffolds sustained La3+ release, promoted osteogenic gene expression, modulated immune responses, and enhanced in vivo bone defect regeneration (Xu et al., 2022; Supplementary Table S1, entry 16). Strontium-substituted magnesium phosphate scaffolds showed reliable mechanical properties and sustained Sr2+ release in vitro, supporting their relevance for osteoporosis-oriented bone replacement (Meininger et al., 2016).

Strontium-based scaffolds are especially relevant because Sr2+ can promote osteoblast activity while reducing osteoclast activity. In a murine critical-size femoral defect model, 3D-printed Sr-doped β-tricalcium phosphate (TCP) scaffolds altered nuclear factor-kappa beta (NF-κB) and vascular endothelial growth factor receptor-2 (VEGFR-2) promoter activity during healing and increased soft and new bone formation compared with β-TCP alone (Tohidnezhad et al., 2020; Supplementary Table S1, entry 17). A fishnet-inspired 3D scaffold combining mesh-like electrospun membranes with strontium-substituted hydroxyapatite (Sr-HAp)-enriched polycaprolactone (PCL)/silk fibroin nanofibers achieved near-complete repair in an osteoporotic cranial defect model within 8 weeks, attributed to combined angiogenic, osteogenic, and anti-osteoclastic effects (Xiao L. et al., 2025; Supplementary Table S1, entry 18).

3.3 Polymer, composite, and bioactive glass scaffolds

Polymer-based 3D-printed scaffolds allow drug incorporation, controlled degradation, and patient-specific shaping. Directly printed PLA and PCL scaffolds loaded with ciprofloxacin or dexamethasone retained mechanical properties and released biologically active antibacterial or anti-inflammatory agents in vitro (Farto-Vaamonde et al., 2019; Stepanova et al., 2023), although further osteoporotic in vivo validation is required. Personalized polyetheretherketone (PEEK) bone plate scaffolds coated with hydroxyapatite, tantalum, or titanium promoted osteogenic cell proliferation and differentiation in vitro, and HAp-coated PEEK accelerated bone healing in a rabbit femoral defect model (Zhang W. et al., 2025; Supplementary Table S1, entry 19).

Bioactive glass and calcium silicate systems have been used as carriers for osteogenic and anti-inflammatory compounds. A 3D-printed bioactive glass scaffold coated with poly(lactic-co-glycolic) acid (PLGA)/simvastatin showed sustained simvastatin release, preserved osteogenic activity in vitro, and improved rat calvarial bone regeneration, with increased BMP-2 and vWF expression (Chiu et al., 2024; Supplementary Table S1, entry 20). Ginsenoside Rb1-loaded mesoporous calcium silicate/calcium sulfate scaffolds promoted stem cell proliferation, osteogenic protein expression, inflammation inhibition, and hard tissue regeneration in vivo (Chen et al., 2021; Supplementary Table S1, entry 21).

4 Local delivery of osteoporosis-relevant therapeutics

Local delivery is a dominant strategy because it can concentrate osteoanabolic or antiresorptive drugs at the defect while reducing systemic exposure. 3D-printed scaffolds loaded with teriparatide, i.e., the 1–34 N-terminal fragment of parathyroid hormone (PTH 1–34), have shown strong osteoanabolic potential. A photocurable mesoporous bioactive glass (PMBG)/TCP scaffold coordinated with PTH(1–34) bidirectionally regulated bone homeostasis by promoting formation and inhibiting resorption, partly through suppression of fibrogenic activation protein (Ren et al., 2023; Supplementary Table S1, entry 22). Likewise, a dual-controlled release PTH(1–34) scaffold based on PLGA microspheres embedded within a chitosan/nano-hydroxyapatite hydrogel ink produced sustained biphasic release and significantly improved bone volume fraction and trabecular thickness in ovariectomized rat calvarial defects (Leung et al., 2026; Supplementary Table S1, entry 23).

Bisphosphonate delivery has also been widely explored. Zoledronic acid-loaded coatings on magnesium alloy scaffolds improved osteoporotic bone defect repair (Zhang J. et al., 2025; Supplementary Table S1, entry 24), while alendronate-functionalized PLGA/HAp/MgO scaffolds reduced resorption and enhanced bone formation (Ran et al., 2023; Xia et al., 2026; Supplementary Table S1, entries 1 and 2). Sequential release systems are particularly attractive because they can address multiple phases of healing. For example, β-TCP scaffolds sequentially releasing IL-4 and alendronate first promoted M2 macrophage polarization and subsequently inhibited osteoclast activity while supporting osteogenic differentiation, resulting in superior regeneration in an osteoporotic rat femoral defect model (Yang et al., 2025; Supplementary Table S1, entry 25).

Other therapeutic strategies rely on the local delivery of bioactive small molecules, vitamins, ions, or cell-derived signalling factors. Ethyl-2,5-dihydroxybenzoate, a component of Rubus coreanus extract, released from PLGA-coated 3D-printed titanium implants reduced resorption and increased peri-implant bone formation in an osteoporotic model (Kwon et al., 2018; Supplementary Table S1, entry 26). Vitamin D3 released from 3D-printed calcium phosphate scaffolds inhibited osteoclast-mediated resorption and supported osteoblast morphology (Vu and Bose, 2019), while combined curcumin/vitamin D3 delivery from calcium phosphate matrices enhanced bone regeneration and simultaneously provided anti-cancer activity against osteosarcoma cells (Jo et al., 2025; Supplementary Table S1, entry 27).

Beyond conventional drug delivery, biofabricated scaffolds have been developed to deliver therapeutic ions and stimulate endogenous regenerative pathways. 3D-bioprinted PCL/strontium-doped calcium silicate (SrCS) scaffold combined with a gingival fibroblast-laden collagen layer was designed to mimic the hierarchical organization of hard and soft periodontal tissues. The SrCS phase provided sustained release of Sr and Si ions and promoted hydroxyapatite formation, while the cell-laden collagen compartment enhanced the secretion of regenerative factors, including BMP-2, VEGF, and fibroblast growth factor 2 (FGF-2). The construct increased alkaline phosphatase (ALP), bone sialoprotein, and osteocalcin expression in vitro and significantly improved trabecular thickness, bone volume fraction, and new bone formation in an ovariectomized and glucocorticoid-induced osteoporotic rabbit model (Wang et al., 2021; Supplementary Table S1, entry 28). This study highlights the potential of combining bioactive ion delivery with cell-mediated release of osteogenic and angiogenic signals within a single biofabricated platform for osteoporotic tissue repair.

Collectively, these studies indicate that combining structural support with local delivery of osteoanabolic, antiresorptive, immunomodulatory, or antioxidant agents generally outperforms single-function scaffolds, although direct comparisons among different material platforms and therapeutic strategies remain scarce.

5 4D-printed and stimuli-responsive scaffolds: design and in vivo evidence

Conventional 3D-printed scaffolds primarily provide structural support, controlled pore architecture, and local bioactivity. Their advantages include reproducibility, tunable mechanical properties, anatomical customization, and a relatively advanced stage of translational development (Qiao et al., 2020; Jin et al., 2025; Alvarez-Lorenzo et al., 2026).

In contrast, 4D-printed or stimuli-responsive scaffolds incorporate temporal functionality, enabling their properties or biological activity to evolve in response to internal or external cues (Zarur et al., 2023). These systems are particularly attractive for osteoporosis because bone healing requires the sequential coordination of immune modulation, osteoclast inhibition, angiogenesis, and osteogenesis. Responsive scaffolds can exploit pathological features of the osteoporotic microenvironment, including acidity, oxidative stress, chronic inflammation, and dysregulated remodeling, to achieve controlled therapeutic delivery (Che et al., 2026; Wang et al., 2026; Supplementary Table S1, entries 29 and 30). However, challenges related to stimulus penetration, response kinetics, long-term stability, manufacturing reproducibility, and regulatory approval remain significant barriers to clinical translation.

Several strategies have been explored to harness microenvironment-responsive behavior. SrCO3@PCL/polydopamine (PDA) scaffolds released Sr2+ under acidic conditions, suppressing osteoclast activity, promoting M2 macrophage polarization, and enhancing bone regeneration in osteoporotic defect (Du et al., 2025; Supplementary Table S1, entry 31). Similarly, melatonin-loaded zeolitic imidazolate framework (ZIF-8) nanoparticles incorporated in gelatin methacryloyl (GelMA) hydrogel coatings provided pH-responsive release of Zn2+ and melatonin, reducing oxidative stress, restoring mitochondrial function, stimulating BMSC osteogenesis, inhibiting osteoclastogenesis, and improving osseointegration in ovariectomized rats (Li et al., 2026; Supplementary Table S1, entry 32).

Temperature-responsive systems have also enabled temporally programmed delivery. Collagen coatings containing free 4-octyl itaconate and BMP-9-loaded ZIF-8 particles remained fluid during scaffold coating (4 C) and gelled at physiological temperature after implantation. This platform provided rapid release of the anti-inflammatory agent followed by sustained osteogenic stimulation, resulting in improved bone–implant integration and accelerated regeneration in osteoporotic rats (Che et al., 2026; Supplementary Table S1, entry 29).

External stimuli offer additional opportunities for dynamic control. A tannic-acid-based photothermal hydrogel coating deposited on 3D-printed titanium scaffolds incorporated Prussian blue, quercetin, osteogenic growth peptide, and SDF-1α. Upon near-infrared irradiation, the system enhanced self-repair properties while promoting cell recruitment, osteogenesis, ROS scavenging, anti-inflammatory activity, anti-senescence effects, and M2 macrophage polarization in vivo (Wang C. et al., 2026; Supplementary Table S1, entry 30). Likewise, near-infrared-responsive MXene/PLA/icaritin scaffolds employed mild photothermal activation to trigger drug release and accelerate bone repair in a rat vertebral fusion model (Xi et al., 2025; Supplementary Table S1, entry 33).

Although not intended for defect filling, several 3D-printed drug-delivery platforms illustrate how additive manufacturing can enable stimulus-controlled osteoporosis therapies. Hollow microneedle arrays improved denosumab delivery and bone mineral recovery compared with conventional subcutaneous administration (Uddin et al., 2024; Supplementary Table S1, entry 34), while multimicrochannel microneedles combined with microcurrent stimulation enhanced transdermal parathyroid hormone delivery and osteoanabolic responses (Mo et al., 2025; Supplementary Table S1, entry 35). A magnetically actuated implantable reservoir system containing 3D-printed drug capsules further demonstrated sequential on-demand release and superior efficacy in a disuse osteoporosis model compared with systemic administration or conventional sustained-release approaches (Hu et al., 2025; Supplementary Table S1, entry 36).

6 Human-oriented studies and clinical translation

Despite extensive in vivo preclinical evidence, true human clinical studies of 3D- or 4D-printed scaffolds specifically for osteoporotic bone regeneration remain very limited. Existing human-oriented studies are mainly computational, biomechanical, anatomical, cadaveric, or device-development studies rather than therapeutic trials. This is an important translational gap: most evidence supports biological plausibility and animal efficacy, but not yet clinical effectiveness in osteoporotic patients.

Several studies have designed patient-specific spinal implants for osteoporotic anatomy. Anatomical contour titanium 3D-printed oblique lumbar interbody fusion cages with porous lattice structures and embedded fixation screws were optimized using finite element analysis and weight topology optimization based on osteoporotic endplate morphology (Lai et al., 2023). These cages showed improved stability, lower endplate stress, and mechanical resistance exceeding relevant standards. Similarly, posterior lumbar interbody fusion cages with anatomical curved surfaces and internal lattices achieved improved stress transmission and biomechanical strength compatible with standard requirements (Huang et al., 2023).

Fixation in osteoporotic bone is another clinically relevant challenge. Although not a clinical study, a hybrid titanium 3D-printed suture anchor with an expandable wing mechanism demonstrated higher failure strength than a commercially available solid anchor in osteoporotic and severely osteoporotic bone models (Chen et al., 2022). In vivo implantation in pigs further showed bone ingrowth along the anchor contour comparable to that of the commercial device, supporting its translational potential (Supplementary Table S1, entry 37). A recent biomechanical study of 3D-printed titanium implants with integrated locking plate systems also reported that locking fixation improved yield load, fatigue survival, and construct stability compared with nonlocking fixation, although in vivo validation is still required (Kang et al., 2026).

Cadaveric and replica-model studies further support translational evaluation. A biomechanical cadaver study using 3D-printed bone models with osteoporotic and normal cancellous bone volume fraction found that subchondral fixation instrumentation did not materially alter articular pressures, suggesting patient-specific models can complement cadaver testing (Pereira et al., 2026). Ultrasound computed tomography combined with finite element analysis of 3D-printed trabecular bone replicas estimated mechanical stiffness with promising accuracy, supporting future non-invasive fracture-risk assessment (Althomali et al., 2018).

Human imaging phantoms and anatomical models provide another translational bridge. 3D-printed calcaneus phantoms have been developed for microwave imaging, photoacoustic/quantitative ultrasound calibration, and bone strontium measurement. These models do not treat osteoporosis directly, but they may improve diagnostic monitoring, implant planning, and preclinical calibration before human studies (Amin et al., 2020; Cannatà et al., 2024; Xu et al., 2024; Bickley et al., 2025).

The clinical translation of 3D-printed biomaterials and implants is advancing, although robust evidence from large-scale randomized trials remains limited. Nevertheless, several ongoing and recent clinical studies provide insight into their potential advantages in both spinal and maxillofacial applications. In spinal surgery, a prospective observational cohort study (NCT04086784) is evaluating 3D-printed porous titanium alloy cages compared with conventional PEEK cages in osteoporotic patients undergoing posterior lumbar interbody fusion (PLIF). The rationale is that the porous architecture of titanium cages may enhance osseointegration, accelerate fusion, and consequently reduce pedicle screw loosening. Primary outcomes include screw loosening and fusion rates at 6 months, with additional longitudinal assessment of disability and pain using validated clinical scales such as the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS).

A related multicenter prospective cohort study (NCT05981222) investigates biomechanically optimized 3D-printed titanium cages (Osteo Match), specifically designed to match the elastic modulus of osteoporotic bone. This approach aims to mitigate the mechanical mismatch associated with traditional implants, thereby reducing cage subsidence and improving fusion outcomes. Radiographic measures of subsidence and fusion, together with clinical outcome scores, are being assessed over multiple follow-up time points.

Beyond spinal indications, additive manufacturing is also being explored in craniofacial reconstruction. A randomized controlled trial (NCT06773923) is assessing patient-specific, resorbable PCL scaffolds for maxillary and mandibular bone regeneration. This study compares the osteogenic potential of 3D-printed scaffolds with conventional guided bone regeneration techniques using PTFE membranes and xenografts. Primary endpoints include histological bone formation and biomarker expression, while secondary outcomes encompass patient-reported quality of life, postoperative complications, and pain.

Collectively, these studies underscore the growing clinical interest in 3D-printed solutions, particularly in improving osseointegration, achieving better biomechanical compatibility, and enabling patient-specific treatments. However, most current evidence is derived from observational designs or early-phase trials with relatively small cohorts. Therefore, further high-quality randomized controlled trials with long-term follow-up are required to establish definitive clinical benefits and guide widespread adoption.

7 Challenges and future directions

The main scientific challenge is that osteoporotic bone repair is multifactorial. A scaffold that only stimulates osteogenesis may fail if inflammation, oxidative stress, osteoclast activity, or poor mechanical fixation are not addressed. The most promising systems therefore combine multiple functions: structural support, osteogenic stimulation, antiresorptive activity, immune regulation, angiogenesis, and oxidative stress control. Multi-scale biomimetic hydrogel scaffolds incorporating alendronate sodium, cerium ion nanoparticles, collagen-methacrylate hydrogel, and TCP scaffolds exemplify this direction by promoting osteogenesis, angiogenesis, mitochondrial function, and Wnt signaling in osteoporotic defect models (Jin et al., 2025; Supplementary Table S1, entry 38).

A second challenge is model standardization. Most in vivo studies rely on ovariectomized rodent models, calvarial or femoral defects, or implant osseointegration models. These are useful but do not fully reproduce human fragility fractures, spinal fusion, joint arthroplasty, or elderly multimorbidity. More large-animal studies, mechanically loaded models, aged animals, and comparisons with current clinical standards are needed before human translation.

A third challenge is clinical manufacturability. Patient-specific implants require consistent printing quality, sterilization, quality control, and regulatory documentation. For 4D systems, the challenge is greater because the device may combine scaffold, drug, biologic, and stimulus-responsive behavior. Future studies should also address scalable manufacturing, release kinetics, degradation, mechanical fatigue, immunogenicity, systemic toxicity, and long-term safety and osseointegration under osteoporotic conditions.

8 Conclusion

3D-printed scaffolds have advanced substantially for osteoporotic bone regeneration, moving from inert porous supports to bioactive, drug-delivering, immunomodulatory, and antioxidant platforms. In vivo preclinical studies consistently show improved bone formation, osseointegration, angiogenesis, or fixation when scaffold architecture is combined with osteoporosis-specific biological strategies. 4D and stimuli-responsive systems represent the next stage, offering temporal and microenvironment-adaptive control over repair. However, the field remains predominantly preclinical. Human studies are currently indirect and include patient-specific design, finite element modeling, biomechanical testing, cadaveric studies, and diagnostic phantoms rather than therapeutic clinical trials. Translation will depend on rigorous long-term in vivo validation, large-animal studies, standardized outcomes, and early-phase clinical trials in osteoporotic patients.

Future clinical translation will require not only improved biological performance but also scalable manufacturing, reproducible fabrication, long-term safety, and regulatory compliance.

Generative AI statement

The author(s) declared that generative AI was used in the creation of this manuscript. ChatGPT (OpenAI, GPT-5.5) was used to improve the English language and readability of the manuscript and to assist with the preparation of Figure 1. The authors conceived the figure, verified its scientific accuracy, and take full responsibility for its content. The authors reviewed and edited all AI-assisted suggestions and take full responsibility for the final content.

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Supplementary material

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fbiom.2026.1937864/full#supplementary-material

Supplementary material Supplementary material at the source

Footnotes

Edited by: Bartlomiej Wysocki, Uniwersytet Kardynala Stefana Wyszynskiego w Warszawie, Poland

Reviewed by: Nadia S. Mahmoud, National Research Centre, Egypt

Statements

Conflict of interest

The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Funding

The author(s) declared that financial support was received for this work and/or its publication. The work was supported by Spain Ministerio de Ciencia, Innovación y Universidades MICIU/AEI/10.13039/501100011033 (PID2023-150422OB-I00 and PID2023-150693OB-I00), ERDF A way of making Europe, cofunded by the European Union, and Xunta de Galicia (ED431C 2024/09).

Author contributions

MC-R: Formal Analysis, Writing – original draft, Investigation, Validation, Writing – review and editing. LD-G: Writing – original draft, Visualization, Writing – review and editing, Investigation, Formal Analysis, Supervision. YS: Writing – review and editing, Investigation, Writing – original draft. CA-L: Writing – review and editing, Writing – original draft, Funding acquisition, Supervision, Resources, Investigation, Software, Project administration, Validation, Conceptualization, Methodology, Formal Analysis. MV-R: Writing – review and editing, Conceptualization, Supervision, Writing – original draft, Investigation.

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Citation

Castro-Rodríguez, M., et al. (2026). 3D- and 4D-printed scaffolds for osteoporotic bone regeneration: translational insights from in vivo preclinical and human-oriented studies. Frontiers in Biomaterials Science, Volume 5. https://doi.org/
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5 - 2026

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Copyright © 2026 Castro-Rodríguez, Diaz-Gomez, Sanz, Alvarez-Lorenzo and Vallet-Regí.

License: https://creativecommons.org/licenses/by/4.0/

*Correspondence: Carmen Alvarez-Lorenzo; María Vallet-Regí

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