Drug updated on 9/4/2024
| Dosage Form | Injection (subcutaneous; 3120 mcg/1.56 mL) |
| Drug Class | Human 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
- Tymlos (abaloparatide) is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who are intolerant to other available osteoporosis therapy. It is also used to increase bone density in men with osteoporosis at high risk for fracture or patients who are intolerant to other available osteoporosis therapy.
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- In postmenopausal women with osteoporosis, abaloparatide (ABL) significantly outperformed teriparatide (TPTD) at 24 weeks for femoral neck (WMD = 1.58) and total hip BMD (WMD = 1.46) but not lumbar spine BMD. ABL had the highest probability (76.06% at 12 months) of being most effective for lumbar spine BMD compared to other drugs.
- In men with osteoporosis, ABL, along with bisphosphonates, denosumab, and teriparatide, significantly improved BMD at lumbar spine, total hip, and femoral neck compared to placebo.
- Fracture Risk Reduction: In postmenopausal women with osteoporosis, ABL had the highest probability of reducing vertebral fractures (79%), nonvertebral fractures (70%), and wrist fractures (53%) compared to other treatments. Zoledronate was the only drug significantly reducing both vertebral and nonvertebral fractures in primary prevention, while ABL and several other drugs were effective in secondary prevention.
- Postmenopausal Women with Osteoporosis: The incidence of hypercalcemia was 51% lower in the ABL group compared to TPTD, though higher risks of nausea and palpitations were observed with ABL compared to placebo. There was no significant difference in serious adverse events or deaths between ABL and TPTD. ABL and PTH (1-84) were associated with an increased risk of withdrawal in secondary prevention.
- Safety Limitations: The safety conclusions were limited due to the exclusion of adverse events and drug costs in the multiple drugs comparison (NMA).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Tymlos (abaloparatide) Prescribing Information. | 2023 | Radius Health, Inc., Waltham, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis—2020 update. | 2020 | Endocrine Practice |
| Pharmacological management of osteoporosis in postmenopausal women: an Endocrine Society* clinical practice guideline. | 2019 | The Journal of Clinical Endocrinology & Metabolism |