From the Guidelines
Abaloparatide is recommended for patients with osteoporosis at high risk of fracture, particularly those who have failed other therapies or have severe osteoporosis, as it stimulates bone formation through binding to the PTH1 receptor, leading to increased osteoblast activity and new bone formation 1. The standard regimen is 80 micrograms administered as a daily subcutaneous injection for up to 24 months. Treatment should be accompanied by calcium (1000-1200 mg) and vitamin D (600-800 IU) supplementation daily. This anabolic mechanism makes it particularly effective for patients with severe osteoporosis or those who have failed other therapies. After completing the 24-month course, patients should transition to an antiresorptive medication like a bisphosphonate to maintain bone density gains. Abaloparatide is contraindicated in patients with hypercalcemia, bone metastases, history of skeletal malignancies, or Paget's disease. Common side effects include orthostatic hypotension, dizziness, nausea, and hypercalciuria, so patients should be monitored periodically with laboratory tests during treatment. According to the latest evidence-based guideline for the management of osteoporosis in men, abaloparatide is considered an appropriate first-line treatment for men with osteoporosis at a very high risk of osteoporotic fracture 1. The efficacy summary of the studies reported above supports the utility of abaloparatide in improving fracture outcomes and accruing bone mineral density (BMD) in men with osteoporosis 1. It is essential to note that abaloparatide should be used in accordance with the recommendations of the regulatory authorities, and patients should be carefully selected based on their fracture risk assessment and medical history 1.
From the FDA Drug Label
TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog 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. (1.1) 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. (1.2)
The recommended use of Abaloparatide for treating osteoporosis is:
- Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
- 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. The recommended dosage is 80 mcg subcutaneously once daily 2.
From the Research
Recommended Use of Abaloparatide for Treating Osteoporosis
- Abaloparatide is a parathyroid hormone-related protein analog used for the treatment of postmenopausal osteoporosis in women who are at high risk for fracture or who fail antiresorptive therapy 3.
- The recommended dosage of abaloparatide is 80 μg administered subcutaneously once daily 4.
- Abaloparatide has been shown to reduce the risk of vertebral, nonvertebral, major osteoporotic, and clinical fractures compared with placebo and teriparatide 3, 4.
- Abaloparatide also increases bone mineral density at the lumbar spine, total hip, and femoral neck 4, 5.
Efficacy and Safety of Abaloparatide
- Abaloparatide has been demonstrated to be effective in reducing the risk of new vertebral fractures in postmenopausal women with osteoporosis 4.
- The incidence of hypercalcemia was lower with abaloparatide compared with teriparatide 4.
- Abaloparatide has a potent anabolic activity with reduced effects on bone resorption 5.
- Common adverse events associated with abaloparatide include palpitations, increased heart rate, and administration site reactions 6, 3.
Patient Selection and Treatment Targets
- Abaloparatide is recommended for patients at very high fracture risk, and the goal of treatment is to mitigate fracture risk by achieving T-scores at least above -2.5 7.
- The probability of achieving bone mineral density treatment targets with abaloparatide should be considered when determining which treatment to initiate in patients at high or very high risk of fracture 7.