What is the use of Teriparatide (Forteo)?

From the Guidelines

Teriparatide should be considered as a treatment option for females with primary osteoporosis at very high risk of fracture, as suggested by the American College of Physicians in their 2023 living clinical guideline 1.

Key Points

• Teriparatide is a synthetic form of parathyroid hormone (PTH 1-34) that stimulates new bone formation by preferentially activating osteoblasts over osteoclasts.
• It is administered as a daily subcutaneous injection of 20 micrograms for up to 24 months.
• Common side effects include dizziness, leg cramps, and mild hypercalcemia, and blood calcium levels should be monitored periodically during treatment.
• Teriparatide is contraindicated in patients with Paget's disease, unexplained elevated alkaline phosphatase, prior radiation therapy to the skeleton, bone metastases, or history of skeletal malignancies.

Treatment Considerations

• The American College of Physicians recommends bisphosphonates as the initial pharmacologic treatment for primary osteoporosis to reduce the risk of fractures 1.
• Teriparatide may be considered as a second-line treatment option for females with primary osteoporosis at very high risk of fracture, due to its potential to increase the risk of serious adverse events 1.
• The decision to use teriparatide should be based on a discussion of patient preferences, fracture risk profile, and benefits, harms, and costs of medications, as suggested by the American College of Physicians in their 2017 clinical practice guideline update 1.

Monitoring and Follow-up

• Patients on teriparatide should be monitored periodically for blood calcium levels and adverse events.
• After completing the 24-month course, patients typically transition to an antiresorptive medication to maintain the bone density gains achieved during treatment.

From the FDA Drug Label

1 INDICATIONS AND USAGE Teriparatide injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy

In postmenopausal women with osteoporosis, teriparatide injection reduces the risk of vertebral and nonvertebral fractures. To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.

The main uses of Teriparatide are:

• Treatment of postmenopausal women with osteoporosis at high risk for fracture
• Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
• Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture 2

From the Research

Teriparatide Overview

• Teriparatide is an anabolic agent used in the treatment of osteoporosis, particularly in patients at high risk of fracture 3, 4, 5.
• It works by increasing bone formation and altering the levels of bone formation and resorption markers, ultimately improving bone mineral density (BMD) and reducing the risk of fractures 3, 4, 6, 7.

Efficacy and Safety

• Studies have shown that teriparatide is effective in reducing the risk of vertebral fractures and improving BMD in patients with osteoporosis, including those with postmenopausal osteoporosis, idiopathic or hypogonadal osteoporosis, and glucocorticoid-induced osteoporosis 3, 4, 6, 7.
• Teriparatide has been shown to be generally well-tolerated, with common adverse effects including injection-site pain, nausea, headaches, leg cramps, and dizziness 3, 5.
• The use of teriparatide has been limited to 24 months, after which antiresorptive therapy should be initiated to maintain BMD 4, 5.

Comparison to Other Treatments

• Teriparatide has been compared to bisphosphonates and denosumab in several studies, with results showing that teriparatide is superior to bisphosphonates in decreasing the risk of fracture and improving BMD 7.
• Denosumab has been shown to be similar to bisphosphonates in reducing the risk of fracture, but superior in improving BMD 7.
• The combination of teriparatide with antiresorptive agents has not been shown to be more effective than teriparatide monotherapy 5.

Patient Selection

• Teriparatide is best reserved for patients with osteoporosis at high risk of fracture, or for patients who have unsatisfactory responses to or intolerance of other osteoporosis therapies 3, 5.
• Patients with severe osteoporosis may benefit from treatment with teriparatide, which has been shown to reduce the risk of vertebral fractures compared to standard care 6.