Abaloparatide

(Tymlos®)

Tymlos®

Drug updated on 10/30/2024

Dosage FormInjection (subcutaneous; 3120 mcg/1.56 mL [2000 mcg/ml])
Drug ClassHuman parathyroid hormone related peptide analogs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy
  • Indicated for the treatment to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.

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Summary
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  • This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
  • Bone Mineral Density (BMD) Improvement: Abaloparatide (ABL) significantly improved BMD, showing superior increases at the femoral neck (WMD = 1.58, 95% CI [0.52, 2.63]) and total hip (WMD = 1.46, 95% CI [0.59, 2.32]) compared to placebo and teriparatide (TPTD). It was also identified as one of the most effective treatments for increasing BMD across multiple sites in postmenopausal women with osteoporosis.
  • Fracture Risk Reduction: ABL demonstrated strong efficacy in reducing vertebral and non-vertebral fractures. It was identified as the most effective treatment for reducing vertebral fractures in a network meta-analysis and showed comparable fracture prevention efficacy to other treatments like romosozumab and denosumab in postmenopausal women.
  • Comparative Effectiveness: Compared to teriparatide, ABL showed greater BMD improvements and lower rates of hypercalcemia. While romosozumab had higher efficacy in reducing all types of fractures, ABL remained highly effective in improving BMD and reducing fracture risk.
  • General Safety Profile: Abaloparatide (ABL) demonstrated a favorable safety profile, showing no significant differences in serious adverse events or deaths compared to teriparatide (TPTD). ABL had a 51% lower incidence of hypercalcemia than TPTD but higher risks of nausea and palpitations compared to placebo.
  • Comparative Safety: ABL had fewer severe adverse events compared to romosozumab in some analyses, and no significant differences in serious adverse events were observed when compared to bisphosphonates and denosumab.
  • Safety in Chronic Kidney Disease (CKD): In patients with CKD stages 3-4, ABL did not show a significant difference in adverse events compared to placebo.
  • Abaloparatide (ABL) demonstrated significant benefits in improving bone mineral density (BMD) and reducing fracture risk in postmenopausal women with osteoporosis, especially those at high risk for fractures. It also showed effectiveness in men with primary osteoporosis, indicating similar treatment potential across genders. In patients with chronic kidney disease (CKD) stages 3-5D, ABL may reduce vertebral fractures, though its effects on clinical fractures and BMD improvement in severe CKD remain uncertain.

Product Monograph / Prescribing Information

Document TitleYearSource
Tymlos (abaloparatide) Prescribing Information.2023Radius Health, Inc., Waltham, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The antifracture efficacy of vitamin D in adults - are we assessing it reliably? A systematic review2023Endokrynologia Polska
Efficacy of osteoporosis pharmacological treatments in men: a systematic review and meta-analysis2023Aging Clinical and Experimental Research
Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials2023BMJ (Clinical Research Ed.)
Is abaloparatide more efficacious on increasing bone mineral density than teriparatide for women with postmenopausal osteoporosis? An updated meta-analysis2023 Journal of Orthopaedic Surgery and Research
Pharmacological Therapies for Osteoporosis: A Bayesian Network Meta-Analysis2022Medical Science Monito
Importance of Time Point-Specific Indirect Treatment Comparisons of Osteoporosis Treatments: A Systematic Literature Review and Network Meta-Analyses2022Clinical Therapeutics
Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D2021The Cochrane Database of Systematic Reviews
An Updated Systematic Review of Cost-Effectiveness Analyses of Drugs for Osteoporosis2021PharmacoEconomics
Clinical efficacy and safety of drug interventions for primary and secondary prevention of osteoporotic fractures in postmenopausal women: Network meta-analysis followed by factor and cluster analysis2020PloS One
Comparative efficacy of bone anabolic therapies in women with postmenopausal osteoporosis: A systematic review and network meta-analysis of randomized controlled trials2019Maturitas

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