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Aba6.0
Abaloparatid – Forschung
Überwiegend Mechanismus / Beobachtung
31 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Abaloparatid sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2016–2026 mit einer typischen Studiengröße von 1,139 Teilnehmenden.
Basierend auf 31 Studien · 6 Meta-Analysen · 8 RCTs · 35,763 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Bone density & anabolic bone formationIn der ACTIVE-Phase-3-RCT sanken neue Wirbelkörperfrakturen über 18 Monate um ~86% gegenüber Placebo; auch nonvertebrale Frakturen wurden reduziert; die BMD an Wirbelsäule/Hüfte/Schenkelhals stieg signifikant an · 6-18 Monate
Überwiegend Mechanismus / Beobachtung30 Studien
Fracture & skeletal endpoints
Überwiegend Mechanismus / Beobachtung11 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung9 Studien
Aktives Forschungsgebiet
25 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2025
201620212026
1RCTn=2,463 · very large study2016
Among postmenopausal women with osteoporosis, the use of subcutaneous abaloparatide, compared with placebo, reduced the risk of new vertebral and nonvertebral fractures over 18 months.
Miller PD, Hattersley G, Riis BJ, Williams GC, Lau E, Russo LA, Alexandersen P, Zerbini CA, Hu MY, Harris AG, Fitzpatrick LA, Cosman F, Christiansen C; ACTIVE Study Investigators. · JAMA (2016)
Pivotal phase-3, double-blind ACTIVE RCT (n=2463 postmenopausal women, mean age 69) randomized to abaloparatide 80 µg/day, placebo, or open-label teriparatide 20 µg/day subcutaneously for 18 months
Abaloparatide is a selective activator of the PTH type-1 receptor; new morphometric vertebral fractures occurred far less frequently than placebo (~86% relative reduction) and nonvertebral fractures were also reduced
BMD increases were greater with abaloparatide than placebo at all sites (all P<0.001)
Understanding the distinct and overlapping molecular mechanisms of osteoporosis is essential for improving fracture prevention and long-term skeletal health.
Lee KI, Chen JH, Chen KH. · International journal of molecular sciences (2026)
Standard antiresorptive agents remain first-line therapies, while anabolic agents such as teriparatide, abaloparatide, and romosozumab provide enhanced benefits in high-risk or drug-suppressed bone states.
Transitional bisphosphonate therapy is essential when discontinuing denosumab, and individualized treatment plans-including drug holidays, lifestyle interventions, and monitoring vulnerable patients-are critical for optimizing outcomes.
Emerging approaches such as small interfering RNA (siRNA)-based therapeutics, anti-sclerostin agents, digital monitoring technologies, and regenerative strategies show promise for future precision medicine management.
Potential differences in their effects on bone mineral density and their antifracture effects offer avenues for differentiation but require further validation in appropriately designed studies.
Fuggle N, Rizzoli R, Beaudart C, Cortet B, Curtis EM, Hiligsmann M, Kaufman JM, Veronese N, Albergaria BH, Al-Daghri N, Alokail M, Brandi ML, Bruyère O, Burlet N, Campusano C, Casado E, Cavalier E, Chandran M, Cooper C, D'Amelio P, Dawson-Hughes B, Ebeling PR, Kanis JA, Kurth A, Matijevic R, McCloskey E, McClung M, Mkinsi O, Njeze N, Radermecker RP, Rannou F, Silverman S, Tüzün Ş, Zakraoui L, Reginster JY, Harvey NC. · Nature reviews. Rheumatology (2025)
A similar potential superiority was suggested for hip fracture in a real-world, observational study.
Side effects of these medications are usually transient, and although a risk of osteosarcoma was suggested by studies using murine models, no such risk has been observed in extensive human studies.
Overall, both teriparatide and abaloparatide have demonstrated convincing clinical effectiveness and cost-effectiveness, with a reassuring safety profile.
Xu F, Wang Y, Zhu X. · Clinical therapeutics (2024)
The incidence of vertebral fracture was lower in the abaloparatide group than in the control group (risk ratio, 0.13; 95% CI, 0.06-0.26; I 2 = 0%).
There was no significant difference in the incidence of adverse events between the abaloparatide and the placebo groups (risk ratio, 1.03; 95% CI, 0.99-1.06; I 2 = 0%).
Implications Abaloparatide has a protective effect on women with postmenopausal osteoporosis.
During the full 43-month treatment period, 0.9% of evaluable women in the ABL/ALN group experienced a new radiographic vertebral fracture vs 5.6% of women in the PBO/ALN group, an 84% relative risk reduction.
Bone HG, Cosman F, Miller PD, Williams GC, Hattersley G, Hu MY, Fitzpatrick LA, Mitlak B, Papapoulos S, Rizzoli R, Dore RK, Bilezikian JP, Saag KG. · J Clin Endocrinol Metab (2018)
Extension of ACTIVE: women who completed abaloparatide (ABL) or placebo (PBO) received up to 24 months of alendronate (ALN); 558 ABL and 581 PBO completers enrolled
Over the full 43 months, vertebral fracture was reduced 84% with ABL/ALN vs PBO/ALN (P<0.001); BMD gains from the anabolic phase were preserved and increased further during the antiresorptive phase
Kaplan-Meier rates for other fracture types were significantly lower with ABL/ALN; a regulatory supplemental analysis found no hip fractures in ABL/ALN vs five in PBO/ALN
Bone anabolic treatments were more effective than bisphosphonates in the prevention of clinical and vertebral fractures, irrespective of baseline risk indicators.
Händel MN, Cardoso I, von Bülow C, Rohde JF, Ussing A, Nielsen SM, Christensen R, Body JJ, Brandi ML, Diez-Perez A, Hadji P, Javaid MK, Lems WF, Nogues X, Roux C, Minisola S, Kurth A, Thomas T, Prieto-Alhambra D, Ferrari SL, Langdahl B, Abrahamsen B. · BMJ (2023)
Systematic review, network meta-analysis and meta-regression of 69 trials (>80,000 postmenopausal women), including the bone anabolic agents abaloparatide and romosozumab
Parathyroid-hormone-receptor agonists (abaloparatide/teriparatide) and romosozumab protected against clinical fractures vs placebo; bisphosphonates were less effective than PTH-receptor agonists (OR 1.49)
PTH-receptor agonists, denosumab and romosozumab were more effective than oral bisphosphonates for vertebral fractures; no harm signals seen, certainty moderate-to-low
Evidence in men and long-term safety remains limited.
Bonifacio M, Ruggiero M, Lucchetti L, Musorrofiti MG, La Cava G, Chiappetta A, Fiorino E, Lo Gullo A, Conforti A. · Journal of clinical medicine (2026)
Primary outcomes were vertebral, non-vertebral, and hip fractures; secondary outcomes included percentage change in BMD and safety endpoints.
Transdermal delivery was less effective, and sequential abaloparatide → antiresorptive therapy further reduced fractures.
New treatments under investigation also hold promise for further improving bone health in postmenopausal osteoporosis.
Sølling AS, Langdahl BL, Cosman F. · Annual review of medicine (2026)
Current therapies for osteoporosis include antiresorptive treatments, including bisphosphonates, denosumab, and raloxifene, and osteoanabolic treatments, including teriparatide, abaloparatide, and romosozumab, which is a dual-action agent.
Sequential therapies aim to optimize fracture prevention and bone density outcomes for long-term management.
Recent guidelines have suggested categorical risk stratification and a goal-directed individualized therapy strategy.
Progress in this field will lead to better treatment of fractures especially those slow or fail to heal.
Bikle D. · Frontiers in endocrinology (2025)
Parathyroid hormone (PTH) in its 1-34 form (teriparatide) and its analog abaloparatide are promising drugs to promote fracture repair.
PTH acts via its receptor (PTHR) which is expressed in essentially all skeletal cells involved in fracture repair.
Its anabolic actions are mediated by a number of interacting pathways including cAMP/PKA, Wnt, BMP, IGF1 and the bidirectional signaling of Ephrin B2/Eph B4.
Future research should explore combination therapies or multi-target strategies to optimize both efficacy and safety.
Chen L, Ji B, Xia C. · Frontiers in endocrinology (2025)
We performed pairwise meta-analysis using Stata 18.0 software to assess the magnitude of effect sizes and the consistency of findings across studies.
Conclusion The results indicate that abaloparatide and teriparatide are significantly superior to other drugs in improving lumbar spine and femoral neck BMD, while oral bisphosphonates is the most effective in improving total hip BMD.
In terms of safety, teriparatide demonstrates the best performance in all adverse events, and oral bisphosphonates shows a clear advantage in reducing severe adverse events.
13Beobachtungsstudien=2,463 · very large study2025
A patient's BMD at baseline and the probability of achieving target T-scores with treatment should be considered when determining that treatment should be initiated in patients at high or very high risk of fracture.
Cosman F, Mitlak BH, Wang Y, Pearman L, Moreira CA, Lewiecki EM, Cummings SR. · Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research (2025)
At baseline, 23% and 74% of women enrolled in ACTIVE had T-scores ≤-2.5 at the TH and LS, respectively.
Over 18 mo of treatment, more than 50% of women were likely to achieve TH T-scores >-2.5, with baseline TH T-scores as low as -2.7 for both abaloparatide and teriparatide.
More than 50% of women were predicted to achieve an LS T-score >-2.5 with a baseline LS T-score as low as -3.3 for abaloparatide or -3.2 on teriparatide.
Abaloparatide-induced bone formation cannot be explained solely by remodeling-based bone formation, indicating the need for further research into modeling-based bone formation.
Hasegawa T, Yamamoto T, Haraguchi-Kitakamae M, Hongo H, Shi Y, Cui J, Liu X, Yao Q, Abe M, Maruoka H, Yokoyama A, Sekiguchi T, Makino A, Amizuka N. · Journal of bone and mineral metabolism (2025)
Additionally, while PTH significantly increases trabecular bone, it also causes cortical porosis.
Our research on the femoral diaphysis showed that PTH administration resulted in the invasion of blood vessels and osteoclasts into the cortical bone.
Abaloparatide acts similarly to teriparatide through the parathyroid hormone receptor type 1 (PTH1R) but may have a wider anabolic window due to its lesser impact on bone resorption.
This narrative review examines current evidence on abaloparatide's potential role in CKD, emphasizing its mechanism of action, efficacy, safety, and relevance for patients with low bone turnover and high fracture risk.
Gifre L, Fusaro M, Lloret MJ, Massó E, Peris P, Nogués X, Gelpi R, Prior-Español Á, Ara J, Cozzolino M, Ureña-Torres PA, Bover J. · Journal of clinical medicine (2025)
These skeletal disorders are associated with markedly increased morbidity and mortality, including a 2- to 9-fold higher risk of hip fractures compared to the general population, prolonged hospitalization, functional decline, and excess postoperative mortality.
PTH analog are poorly prescribed in patients with CKD stage G3 and remain off-label for stages G4-G5D, despite the high prevalence of adynamic bone disease across all stages of CKD.
Abaloparatide, a selective PTH1 receptor agonist, exerts potent anabolic effects with a lower incidence of hypercalcemia than teriparatide and may offer a favourable safety profile in carefully selected patients.
Osteoanabolic drugs are an effective therapeutic strategy for reducing individual fracture risk and treating osteoporosis.
Stumpf U, Kurth A. · Orthopadie (Heidelberg, Germany) (2025)
Teriparatide and abaloparatide are osteoanabolic agents that promote the formation of new bone by activating the PTH1 receptor, significantly reducing the risk of fractures, particularly vertebral fractures.
Teriparatide is approved for use in men and postmenopausal women at high risk of fracture, as well as for the treatment of glucocorticoid-induced osteoporosis.
However, the approval of romosozumab and abaloparatide is currently limited to the treatment of postmenopausal women.
See Instructions for Authors for a complete description of levels of evidence.
Sheth NP, Sheth NP, Smith JR, Winzenrieth R, Humbert L, Wang Y, Boxberger JI, Bostrom MP. · The Journal of bone and joint surgery. American volume (2024)
Conclusions Abaloparatide increases BMD in proximal femoral regions that interact with and support femoral stems, suggesting that abaloparatide may have value for preoperative or potentially perioperative bone health optimization in patients with osteoporosis undergoing THA.
Level of evidence Therapeutic Level III .
See Instructions for Authors for a complete description of levels of evidence.
Yavropoulou MP, Kasdagli MI, Makras P, Diomatari KM, Anastasilakis AD, Mitsikostas DD, Kassi E, Sfikakis PP, Kravvariti E. · Maturitas (2024)
Among 10,529 placebo-treated patients the pooled nocebo-dropout percentage was 3 % for denosumab (average: 0.03; 95 % CI: 0.01-0.05), 1 % for romosozumab (average: 0.01; 95 % CI: 0.00-0.03) and 6 % for teriparatide and abaloparatide (average: 0.06; 95 % CI: 0.05-0.07).
Conclusion Nocebo responses may contribute to treatment discontinuation with subcutaneous anti-osteoporotic drugs in clinical practice.
Higher nocebo-related dropout rates in the higher-risk RCT population (older patients, males, those with prior fractures) show that nocebo mechanisms have the potential to hinder therapeutic efforts to specific populations who would benefit most.
At 12 months, BMD gains were greater with abaloparatide compared with placebo at the lumbar spine (8.48 versus 1.17), total hip (2.14 versus 0.01), and femoral neck (2.98 versus 0.15) (all p<0.0001).
Czerwinski E, Cardona J, Plebanski R, Recknor C, Vokes T, Saag KG, Binkley N, Lewiecki EM, Adachi J, Knychas D, Kendler D, Orwoll E, Chen Y, Pearman L, Li YH, Mitlak B. · J Bone Miner Res (2022)
ATOM phase-3 RCT (n=228 men aged 40-85 with osteoporosis) randomized 2:1 to abaloparatide 80 µg/day or placebo subcutaneously for 12 months; primary endpoint was lumbar-spine BMD
Significantly greater BMD gains with abaloparatide at lumbar spine (~8.5% vs ~1.2%), total hip and femoral neck (all P<0.0001)
Most common adverse events were injection-site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension and headache — consistent with prior studies