What is the recommended treatment regimen for osteoporosis using Micartis (teriparatide)?

Teriparatide (Micartis) Treatment Regimen for Osteoporosis

Teriparatide should be used at a dose of 20 mcg subcutaneously once daily for up to 2 years, followed by an antiresorptive agent, and is primarily indicated for patients with very high fracture risk who have failed or cannot tolerate other osteoporosis treatments. 1, 2

Patient Selection and Indications

Teriparatide is indicated for:

• Postmenopausal women with osteoporosis at high risk for fracture
• Men with primary or hypogonadal osteoporosis at high risk for fracture
• Men and women with glucocorticoid-induced osteoporosis at high risk for fracture
• Patients who have failed or are intolerant to other available osteoporosis therapy 2

Very High Risk Criteria

Patients are considered at very high risk for fracture if they have:

• Older age
• Recent fracture (within past 12 months)
• History of multiple clinical osteoporotic fractures
• Multiple risk factors for fracture
• Failure of other available osteoporosis therapy 1

Dosing and Administration

• Dose: 20 mcg subcutaneously once daily 2
• Administration site: Thigh or abdominal region 2
• Initial administration: Should be done under circumstances where the patient can sit or lie down if symptoms of orthostatic hypotension occur 2
• Duration: Up to 2 years during a patient's lifetime 1, 2
• Supplementation: Consider calcium (1000-1200 mg/day) and vitamin D (800-1000 IU/day) supplementation 3, 2

Storage and Handling

• Store under refrigeration at 2°C to 8°C (36°F to 46°F) at all times
• Minimize time out of refrigerator
• Deliver dose immediately after removal from refrigerator
• Do not freeze 2

Efficacy

Teriparatide has demonstrated significant efficacy in reducing fracture risk:

• Vertebral fractures: 65% reduction compared to placebo (high certainty evidence) 1, 4
• Non-vertebral fractures: 53% reduction compared to placebo 4
• Radiographic vertebral fractures: 69 fewer events per 1000 patients (high certainty) 1
• Clinical vertebral fractures: 45 fewer events per 1000 patients (low certainty) 1
• Any clinical fracture: 27 fewer events per 1000 patients (high certainty) 1
• Hip fractures: No significant difference compared to placebo (low certainty) 1

Compared to bisphosphonates, teriparatide showed:

• 66 fewer radiographic vertebral fractures per 1000 patients (moderate certainty)
• 46 fewer clinical fractures per 1000 patients (low certainty) 1

Post-Treatment Management

Critical: After discontinuation of teriparatide, patients must be transitioned to an antiresorptive agent (such as a bisphosphonate) to prevent rapid bone loss and increased fracture risk 1, 3

Adverse Effects and Monitoring

Common Adverse Effects

• Nausea, dizziness, vomiting, headache, palpitations, leg cramps 1
• Arthralgia, pain 2

Monitoring

• Increased risk for withdrawal due to adverse effects (127 more events per 1000 patients at 36 months) 1
• Monitor for orthostatic hypotension, especially with initial doses 2
• Bone mineral density testing every 1-2 years during treatment 3

Contraindications

• Hypersensitivity to teriparatide or its excipients
• Patients with increased risk of osteosarcoma (open epiphyses, metabolic bone diseases including Paget's disease, bone metastases, prior skeletal radiation therapy, hereditary disorders predisposing to osteosarcoma)
• Hypercalcemic disorders
• Active or recent urolithiasis 2

Special Considerations

• Teriparatide should not be used in children or young adults with open epiphyses 2
• Use with caution in patients with active or recent urolithiasis 2
• Consider discontinuing when pregnancy is recognized 2
• Breastfeeding is not recommended during treatment 2
• Monitor for digitalis toxicity in patients taking digoxin due to potential transient hypercalcemia 2

Treatment Algorithm

1. First-line therapy: Oral bisphosphonates for most patients with osteoporosis 1, 3
2. Second-line therapy: Denosumab for patients with contraindications to bisphosphonates 1
3. Teriparatide indication: Reserve for patients with very high fracture risk or those who have failed other therapies 1, 3
4. Post-teriparatide: Transition to an antiresorptive agent to maintain bone gains 1, 3

This treatment approach optimizes fracture risk reduction while managing potential adverse effects, ultimately improving morbidity, mortality, and quality of life in patients with severe osteoporosis.