Abaloparatide 80micrograms/40microlitres solution for injection 1.5ml pre-filled disposable devices
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Eladynos 80micrograms/40microlitres solution for injection 1.5ml pre-filled pens
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Active and completed clinical studies from ClinicalTrials.gov
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Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 24 · Randomised trials: 3 · 2014–2026
Showing the 50 most relevant studies, sorted by most relevant.
Gregson CL, Armstrong DJ, Avgerinou C, et al.
2025
- Osteoporosis
- Osteoporotic Fractures
- Risk Assessment
The National Osteoporosis Guideline Group (NOGG) has updated the revised UK guideline for the assessment and management of osteoporosis and the prevention of fragility fractures in postmenopausal women, and men age 50 years and older. This guideline is relevant for all healthcare professionals involved in osteoporosis management.IntroductionThe UK National Osteoporosis Guideline Group (NOGG) first produced a guideline on the prevention and treatment of osteoporosis in 2008, with updates in 2013, 2017 and 2021. This paper presents a minor update of the 2021 guideline, the scope of which is to review the assessment and management of osteoporosis and the prevention of fragility fractures in postmenopausal women and men aged 50 years and older.MethodsWhere available, systematic reviews, meta-analyses and randomised controlled trials have been used to provide the evidence base. Conclusions and recommendations have been systematically graded according to the strength of the available evidence.ResultsReview of the evidence and recommendations are provided for the diagnosis of osteoporosis, fracture-risk assessment and intervention thresholds, management of vertebral fractures, non-pharmacological and pharmacological treatments, including duration and monitoring of anti-resorptive therapy, glucocorticoid-induced osteoporosis, as well as models of care for fracture prevention. Recommendations are made for training, service leads and commissioners of healthcare, and for review criteria for audit and quality improvement. Specific 2024 updates include guidance on fracture risk assessment by ethnicity, Parkinson's disease, Down's syndrome and lower-limb amputation; furthermore, the definition of very high fracture risk has been clarified. Hormone replacement therapy (HRT) is now recommended as a first-line treatment option in younger postmenopausal women with high fracture risk and low baseline risk for adverse events; recommendations regarding abaloparatide are included; additional training resources have been added.ConclusionThe guideline provides a comprehensive overview of the assessment and management of osteoporosis for all healthcare professionals involved in its management. This position paper has been endorsed by the International Osteoporosis Foundation and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).
Abstract licence: CC BY
Pan Hong, Ruikang Liu, Saroj Rai, et al.
Journal of Orthopaedic Surgery and Research, 2023
- Osteoporosis
- Osteoporosis, Postmenopausal
- Bone Density Conservation Agents
Liangshi Chen, Bing Ji, Cong Xia
Frontiers in Endocrinology, 2025
- Denosumab
- Diphosphonates
- Network Meta-Analysis as Topic
Fu-rong Xu, Yuru Wang, Xinjian Zhu
Clinical therapeutics, 2024
- Osteoporosis, Postmenopausal
- Spinal Fractures
- Bone Density Conservation Agents
Marco Bonifacio, Marco Ruggiero, Laura Lucchetti, et al.
Journal of Clinical Medicine, 2026
Lu C, Zhang L, Xue C, et al.
2026
- Osteoporosis
- Diphosphonates
- Parathyroid Hormone-Related Protein
BackgroundEvidence from randomized controlled trials (RCTs) on pharmacological management of primary osteoporosis in men is fragmented, making direct comparisons across drug classes difficult, and head-to-head evidence remains limited. We performed a network meta-analysis (NMA) to compare the relative efficacy and safety of commonly used anti-osteoporotic agents in men.MethodsWe systematically searched PubMed, Web of Science, and the Cochrane Library from inception to December 2025 for RCTs enrolling men with primary osteoporosis. Eligible interventions included oral bisphosphonates (OBP), intravenous bisphosphonates (IBP), abaloparatide (ABA), denosumab (DEN), teriparatide (TER), and odanacatib (ODN), compared with placebo/usual care (PLA/CTRL) or active treatments. Primary efficacy outcomes were changes in bone mineral density (BMD) at the lumbar spine (LS), total hip (TH), and femoral neck (FN), preferentially extracted at the time point closest to 12 months (range: 6-24 months). Safety outcomes were any adverse events (AEs) and serious adverse events (SAEs). Pairwise meta-analyses were conducted in Stata 18.0, and NMA in R 4.3.1 under a consistency framework. Treatments were ranked using SUCRA. The protocol was registered in PROSPERO (CRD420261279572).ResultsTwenty-one RCTs (n = 4,409) were included. Compared with PLA/CTRL, TER and ABA significantly improved FN-BMD (TER: MD 2.97, 95% CI 0.74-5.20; ABA: MD 2.83, 95% CI 0.11-5.55), and OBP also showed benefit (MD 1.61, 95% CI 0.15-3.07). For TH-BMD, significant gains were observed for OBP (MD 2.25, 95% CI 1.70-2.81), ABA (MD 2.13, 95% CI 1.43-2.83), and TER (MD 1.12, 95% CI 0.35-1.89); OBP showed a greater increase than TER (MD 1.13, 95% CI 0.32-1.95). For LS-BMD, ABA (MD 7.31, 95% CI 4.25-10.37), TER (MD 6.97, 95% CI 4.53-9.42), and OBP (MD 3.43, 95% CI 1.84-5.02) were superior to PLA/CTRL, and both ABA and TER outperformed OBP (ABA vs OBP: MD 3.88, 95% CI 0.44-7.33; TER vs OBP: MD 3.55, 95% CI 1.08-6.01). Most head-to-head comparisons across active agents were inconclusive with wide uncertainty. Node-splitting suggested no significant local inconsistency (P > 0.05). Safety comparisons for AEs and SAEs were largely imprecise; SUCRA rankings should therefore be interpreted cautiously.ConclusionsIn men with primary osteoporosis, treatment effects on BMD differ by skeletal site: ABA and TER yield larger gains at the lumbar spine, whereas OBP demonstrates robust improvements at the total hip; evidence for femoral neck improvement is clearer for TER and ABA versus PLA/CTRL. However, the extent to which these BMD improvements translate into fracture risk reduction remains uncertain because direct fracture endpoint data were limited in the included RCTs. Safety evidence also remains limited due to imprecision, and SUCRA rankings should therefore be interpreted alongside effect estimates and their uncertainty. Further high-quality, long-term RCTs focusing on fracture outcomes and drug-specific adverse events are warranted.
Abstract licence: CC BY
Cipolloni V, Bonifacio M, Hassny SM, et al.
2026
- Osteoporosis
- Anabolic Agents
- Osteoporotic Fractures
Background and Objectives: Individuals classified as having very high fracture risk remain vulnerable to imminent fractures even when treated with antiresorptive therapies. This meta-analysis evaluated whether initiating treatment with anabolic agents, including teriparatide, abaloparatide, and romosozumab, provides superior fracture protection in this high-risk population. Materials and Methods: A systematic review and meta-analysis of randomized controlled trials was conducted following PRISMA standards. Eligible studies included adults at very high fracture risk, defined by recent or multiple fragility fractures or markedly low bone mineral density, who received anabolic therapy as initial treatment compared with placebo or antiresorptive agents. Outcomes of interest were new vertebral, non-vertebral, hip, and clinical fractures. Effect estimates were pooled using random-effects models. Results: Six randomized trials encompassing 17,872 participants were analyzed. Initiation with anabolic therapy was associated with a marked reduction in incident vertebral fractures. The labeled pooled summary estimate for vertebral fractures was 0.43 (95% confidence interval 0.34-0.54). Significant risk reductions were also observed for clinical fractures (hazard ratio 0.62, 95% confidence interval 0.51-0.75), non-vertebral fractures (pooled effect estimate 0.71, 95% confidence interval 0.59-0.85), and hip fractures (risk ratio 0.65, 95% confidence interval 0.45-0.96). Exploratory subgroup analyses suggested greater vertebral fracture protection versus placebo and persistent benefit versus active antiresorptive comparators. Sequential therapy using an anabolic agent followed by an antiresorptive reduced spinal fracture risk by approximately half. Considerable heterogeneity was noted for vertebral fracture outcomes. Conclusions: Starting osteoporosis treatment with anabolic agents results in faster and more-pronounced fracture risk reduction across all major fracture categories in patients at very high fracture risk. These findings support a shift toward anabolic-first treatment sequencing in this particularly vulnerable group.
Abstract licence: CC BY
Li Z, Zhang L, Xue C, et al.
2026
- Osteoporosis
- Anabolic Agents
- Bone Density Conservation Agents
BackgroundOsteoporosis in men is an increasingly recognized health issue associated with reduced bone mineral density (BMD) and elevated fracture risk. While both antiresorptive and anabolic therapies are recommended in clinical practice, evidence directly comparing these drug classes in male populations remains limited.MethodsWe performed a systematic review and Bayesian network meta-analysis (NMA), registered on PROSPERO (CRD420251151177), to assess the efficacy and safety of pharmacological interventions for male osteoporosis. Randomized controlled trials (RCTs) evaluating alendronate, risedronate, zoledronic acid, denosumab, teriparatide, or abaloparatide were identified from PubMed, Web of Science, and the Cochrane Library through 2025. Primary outcomes included percent change in lumbar spine, femoral neck, and total hip BMD at 12 months. Safety outcomes were all adverse events (AEs) and serious adverse events (SAEs). Category-level meta-analyses were further conducted to compare pooled effects of antiresorptive versus anabolic agents.ResultsEighteen RCTs comprising 19-1199 participants each were included. At the drug level, abaloparatide and teriparatide ranked highest for lumbar spine BMD, while alendronate and abaloparatide demonstrated the most favorable effects for femoral neck and total hip BMD, respectively. Safety profiles were broadly similar, with teriparatide and alendronate showing relatively lower risks of AEs and SAEs. At the class level, anabolic therapies significantly outperformed antiresorptives in improving lumbar spine (MD 6.62, 95% CI 5.01-8.23 vs. 3.58, 95% CI 2.52-4.64) and total hip BMD (3.53, 95% CI 2.18-4.89 vs. 1.98, 95% CI -1.10-5.06), whereas antiresorptives showed modest advantages at the femoral neck (1.66, 95% CI 0.57-2.75 vs. 1.43, 95% CI -0.03-2.86). No significant differences were observed between classes in AEs or SAEs.ConclusionsThis study provides the first comprehensive drug- and class-level synthesis of treatments for male osteoporosis. Anabolic agents confer greater efficacy at the lumbar spine and total hip, while antiresorptives may offer modest benefits at the femoral neck. Safety outcomes were comparable across drug classes, suggesting that treatment choice should primarily be guided by efficacy considerations.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD420251151177.
Abstract licence: CC BY
Y. Ren, A. Vyas
Value in Health, 2024
J.-Y. Reginster, F. Bianic, Ross Campbell, et al.
Osteoporosis International, 2019
- Network Meta-Analysis
- Hip Fractures
- Wrist Injuries
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
11 found
Half-life
Not available
Mechanism
Abaloparatide is an agonist at the PTH1 receptor (PTH1R), a G-protein-coupled re…
Food interactions
3 warnings
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
36%
Half-life
[L740]
Protein binding
70%
[L740]
Volume of distribution
50 L
[L740]
Metabolism
[L740]
Elimination
[L740]
Clearance
168 L/h
[L44737]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Abaloparatide is an osteoanabolic agent that stimulates bone formation.[L740] It was first approved by the FDA on April 28, 2017,[A256748] for the treatment of osteoporosis in postmenopausal women and is also used to increase bone density in men with osteoporosis.[L740] In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended abaloparatide be granted marketing authorization in Europe [L43552] and the drug was fully authorized by the European Commission on December 19, 2022.[L44848]
[L740]
In postmenopausal women with osteoporosis, abaloparatide reduces the risk of vertebral and nonvertebral fractures.
[L740]
Abaloparatide is also indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture) or patients who have failed or are intolerant to other available osteoporosis therapy.
[L740]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 310 interactions
[L44878]
One clinical study reported an accidental overdose in a patient who received 400 mcg in one day, which is five times the recommended clinical dose. This patient experienced asthenia, headache, nausea, and vertigo. Serum calcium was not assessed on the day of the overdose, but
on the following day, the patient’s serum calcium was within the normal range.
Other symptoms of overdose may include hypercalcemia, nausea, vomiting, dizziness, tachycardia, orthostatic hypotension, and headache. Since there is no specific antidote for abaloparatide overdose, it is recommended that overdose is managed with drug discontinuation, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration. Based on the molecular weight, plasma protein binding and volume of distribution, abaloparatide is not expected to be dialyzable.
[L740]
The PTH1R has two conformations with distinct ligand binding profiles. The R0 conformation is a G protein–independent high-affinity conformation, and upon binding, the ligand induces a longer-lasting signalling response that gradually increases cAMP. Due to the prolonged signalling response, ligands selectively binding to the R0 conformation are associated with a risk for increased calcium mobilization and hypercalcemia.[A19105] Conversely, the RG conformation is G-protein–dependent (GTPγS-sensitive) with a shorter signalling response.[A19105][A256778] Abaloparatide binds to the RG conformation with greater selectivity:[A19105][A256753] it induces more transient signalling responses and favours net bone formation over bone resorption. The drug's relatively low risk for hypercalcemia and osteoclast resorption compared to [teriparatide] is attributed to the preferential binding of abaloparatide to the RG conformation.[A256748][A256753]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L740]
[L740]
[L740]
[L740]
[L740]
[L740]
[L44737]
Proteins and enzymes this drug interacts with in the body
PMID:10913300 PMID:18375760 PMID:19674967 PMID:27160269 PMID:30975883 PMID:35932760 PMID:8397094
Ligand binding causes a conformation change that triggers signaling via guanine nucleotide-binding proteins (G proteins) and modulates the activity of downstream effectors, such as adenylate cyclase (cAMP) .
PMID:30975883 PMID:35932760
PTH1R is coupled to G(s) G alpha proteins and mediates activation of adenylate cyclase activity .
PMID:20172855 PMID:30975883 PMID:35932760
PTHLH dissociates from PTH1R more rapidly than PTH; as consequence, the cAMP response induced by PTHLH decays faster than the response induced by PTH PMID:35932760
ATC H05AA04
Chemical identifiers
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Abaloparatide
Additional database identifiers
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Linked open data from Wikidata (Q4834481), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication.