What is the recommended treatment regimen for Abaloparatide (abaloparatide) for osteoporosis?

Recommended Treatment Regimen for Abaloparatide in Osteoporosis

The recommended treatment regimen for abaloparatide is 80 mcg administered as a daily subcutaneous injection for up to 18 months for patients with osteoporosis at high risk of fracture. 1

Dosage and Administration

• Abaloparatide is administered as a subcutaneous injection of 80 mcg once daily 1
• The recommended treatment duration is up to 18 months 2
• The injection is delivered via a pre-assembled disposable single-patient-use pen that contains 30 daily doses 1
• Abaloparatide should be injected into the periumbilical region of the abdomen 1
• No dosage adjustment is required for patients with mild, moderate, or severe renal impairment, though monitoring for adverse reactions is recommended in those with severe renal impairment 1

Patient Selection

• Abaloparatide is indicated for patients at very high risk of osteoporotic fracture 3
• It is considered an appropriate first-line treatment for men with osteoporosis at very high risk of fracture 3, 4
• Abaloparatide is supported by strong data with respect to BMD changes in men with osteoporosis 3
• For patients with glucocorticoid-induced osteoporosis at moderate or very high risk of fracture, abaloparatide is conditionally recommended 3

Sequential Therapy

• After completing abaloparatide treatment, patients should be transitioned to an antiresorptive agent to preserve bone mineral density gains 3, 4
• Sequential therapy starting with abaloparatide followed by an anti-resorptive agent is recommended for individuals at very high risk of fracture 3, 4
• Failure to transition to an antiresorptive agent after discontinuation can result in rebound bone loss 3

Monitoring

• Biochemical markers of bone turnover can be used to assess adherence to therapy 3, 4
• The bone formation marker serum procollagen type I N-propeptide (sPINP) typically peaks at Month 1 at 93% above baseline in women and 133% above baseline in men 1
• The bone resorption marker serum collagen type I cross-linked C-telopeptide (sCTX) typically peaks at Month 3 in women and Month 6 in men 1
• Monitoring for hypercalcemia is recommended, though abaloparatide has shown a lower incidence of hypercalcemia (3.4%) compared to teriparatide (6.4%) 2

Efficacy

• Abaloparatide reduces the risk of new vertebral fractures by approximately 86% and nonvertebral fractures by approximately 43% compared to placebo 5, 2
• It improves bone mineral density at multiple sites including the lumbar spine, femoral neck, and total hip 6, 2
• Abaloparatide treatment improves hip geometry and biomechanical properties, including increased cortical thickness, cross-sectional area, and cross-sectional moment of inertia 6
• Daily administration stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity 1

Contraindications and Special Considerations

• Abaloparatide should be avoided in young adults with open growth plates 3
• Use with caution in patients who may become pregnant due to potential fetal harm 3
• Patients should be optimized for calcium and vitamin D intake based on age-appropriate recommended dietary allowances 3, 4
• Abaloparatide may increase heart rate, with a mean peak increase of 15 beats per minute at 15 minutes after dosing with 80 mcg 1

Limitations and Considerations

• The American College of Physicians notes that evidence on benefits and harms was inconclusive to recommend for or against PTHrP (abaloparatide) in some populations 3
• Long-term safety of abaloparatide in humans has yet to be fully determined 3
• Further research is needed to determine the role of abaloparatide in the treatment of osteoporosis in men 3
• Abaloparatide has shown a somewhat higher occurrence of adverse effects (particularly palpitations and increased heart rate) compared to teriparatide 7