What is the recommended treatment protocol for Teriparatide (parathyroid hormone) in patients with osteoporosis?

Teriparatide Treatment Protocol for Osteoporosis

Teriparatide should be reserved for patients with severe osteoporosis at very high risk for fracture, administered as 20 mcg subcutaneously once daily for up to 24 months, followed by bisphosphonate therapy to maintain bone density gains. 1, 2

Patient Selection Criteria

• Teriparatide is indicated for:

  • Postmenopausal women with osteoporosis at high risk for fracture 2
  • Men with primary or hypogonadal osteoporosis at high risk for fracture 2
  • Men and women with glucocorticoid-induced osteoporosis at high risk for fracture 2

• "Very high risk" patients are defined by:

  • Older age (typically >74 years) 1
  • Recent fracture (within past 12 months) 1
  • History of multiple clinical osteoporotic fractures 1
  • Multiple risk factors for fracture 1
  • Failure of other available osteoporosis therapies 1

Administration Protocol

• Dosage: 20 mcg administered subcutaneously once daily 2
• Administration site: Thigh or abdominal region 2
• Initial administration: Should be given under circumstances where patient can sit or lie down if orthostatic hypotension occurs 2
• Treatment duration: Up to 24 months maximum during a patient's lifetime 2
• Post-treatment: Must be followed by an antiresorptive agent (typically bisphosphonate) to prevent rapid bone loss 1

Efficacy and Monitoring

• Teriparatide reduces risk of:

  • Any clinical fractures (27 fewer events per 1000 patients; high certainty) 1
  • Radiographic vertebral fractures (69 fewer events per 1000 patients; high certainty) 1
  • Clinical vertebral fractures (45 fewer events per 1000 patients; low certainty) 1

• Compared to bisphosphonates, teriparatide:

  • Reduces radiographic vertebral fractures (66 fewer events per 1000 patients; moderate certainty) 1
  • May reduce any clinical fracture (46 fewer events per 1000 patients; low certainty) 1

• Calcium and vitamin D supplementation:

  • Consider supplemental calcium and vitamin D based on individual needs 2
  • Total daily calcium intake should be limited to 1500 mg 3
  • Vitamin D intake up to 1000 IU/day 3

Adverse Effects and Precautions

• Common adverse reactions (>10%): arthralgia, pain, and nausea 2

• Monitor for:

  • Hypercalcemia: Check serum calcium after 1 month of treatment 3
  • Orthostatic hypotension: May occur with initial doses 2
  • Urolithiasis: Consider risk/benefit in patients with active or recent urolithiasis 2

• Contraindications:

  • Hypersensitivity to teriparatide or its excipients 2
  • Patients at increased risk of osteosarcoma including:
    • Open epiphyses 2
    • Metabolic bone diseases including Paget's disease 2
    • Bone metastases or history of skeletal malignancies 2
    • Prior radiation therapy involving the skeleton 2
    • Hereditary disorders predisposing to osteosarcoma 2

Treatment Algorithm

1. First-line therapy: Bisphosphonates are recommended as initial pharmacologic treatment for osteoporosis 1

2. Second-line therapy: Consider denosumab for patients with contraindications to bisphosphonates 1

3. Reserve teriparatide for:

   • Patients with severe osteoporosis 1
   • Patients who have had fractures 1
   • Patients at very high risk for fracture 1
   • Patients who have failed or are intolerant to other osteoporosis therapies 2

4. After teriparatide completion:

   • Transition to bisphosphonate therapy to maintain bone density gains 1
   • Discontinuation without follow-up antiresorptive therapy results in rapid bone loss 1

Clinical Considerations and Pitfalls

• Treatment duration limitation: Use of teriparatide for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture 2

• Avoid concurrent therapy with bisphosphonates as this may reduce teriparatide's effectiveness; sequential therapy is preferred 3

• Mild hypercalcemia can be managed by:

  • Withdrawing dietary calcium supplements 3
  • Reducing the dosing frequency of teriparatide 3

• Teriparatide is significantly more expensive than bisphosphonates, which affects its cost-effectiveness profile 3