Drug updated on 10/30/2024
| Dosage Form | Injection (subcutaneous; 3120 mcg/1.56 mL [2000 mcg/ml]) |
| Drug Class | Parathyroid hormone related peptide [PTHrP(1-34)] 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.
Latest News
Summary
- 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 Title | Year | Source |
|---|---|---|
| Tymlos (abaloparatide) Prescribing Information. | 2023 | Radius Health, Inc., Waltham, MA |