FDA approved Forteo (teriparatide) for Osteoporosis TreatmentFDA approved new osteoporosis drug Forteo for high-risk patients

FDA From the archive Source published November 26, 2002 Summary added August 6, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Forteo for high-risk osteoporosis patients, but limit use to 2 years over a lifetime.

The FDA has approved Forteo (teriparatide), a parathyroid hormone analog, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, for increasing bone mass in men with primary or hypogonadal osteoporosis, and for osteoporosis associated with sustained systemic glucocorticoid therapy. The approval provides a new anabolic option for patients who have failed or are intolerant to other osteoporosis therapies. In a pivotal trial, Forteo significantly reduced the risk of vertebral and nonvertebral fractures compared with placebo. Clinicians should note that Forteo is administered as a daily subcutaneous injection and is intended for use up to 2 years over a patient's lifetime. The drug's efficacy and safety were established in a study of postmenopausal women, with a median exposure of 19 months. This approval offers an important therapeutic alternative for high-risk patients, particularly those who have not responded to antiresorptive agents.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Forteo (teriparatide) is a parathyroid hormone analog (PTH 1-34). It stimulates bone formation by preferentially increasing osteoblastic activity, leading to increased bone mass and strength.

Indication & Patient Population

Forteo is indicated for: - Treatment of postmenopausal women with osteoporosis at high risk for fracture (defined 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. - 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. - 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.

Dosing & Administration

The recommended dosage is 20 mcg subcutaneously once a day. Administer as a subcutaneous injection into the thigh or abdominal region. Forteo is not approved for intravenous or intramuscular use. Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur. Consider supplemental calcium and vitamin D based on individual patient needs. Use of Forteo for more than 2 years during a patient's lifetime should only be considered if the patient remains at or has returned to having a high risk for fracture. Discard the delivery device 28 days after first use.

Key Clinical Trial Data

In a double-blind, placebo-controlled study of 1637 postmenopausal women with osteoporosis (median exposure 19 months), 541 women received Forteo 20 mcg subcutaneously once daily. All women received calcium 1000 mg and vitamin D at least 400 IU daily. Forteo reduced the risk of new vertebral fractures from 14.3% in the placebo group to 5.0% in the Forteo group (p<0.001), an absolute risk reduction of 9.3% and relative risk reduction of 65%. Forteo also significantly reduced the risk of nonvertebral fractures from 5.5% to 2.6% (p<0.05), an absolute reduction of 2.9% and relative reduction of 53%.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Forteo is an anabolic agent for osteoporosis treatment in high-risk patients, including those who have failed or are intolerant to other therapies. It is particularly useful for reducing vertebral and nonvertebral fracture risk in postmenopausal women. Its use is limited to 2 years over a lifetime, and it should be reserved for patients at high risk for fracture.

The U.S. Food and Drug Administration has approved a new drug called Forteo (teriparatide) for the treatment of osteoporosis. Osteoporosis is a condition that makes bones weak and more likely to break. Forteo is a form of parathyroid hormone, which helps the body build new bone. It is given as a daily injection under the skin and is meant to be used for up to two years over a person's lifetime.

Forteo is approved for three groups: postmenopausal women who are at high risk for fractures, men with osteoporosis caused by low sex hormones or for no known reason, and people who have osteoporosis due to long-term use of steroid medicines. In a key study, Forteo significantly reduced the risk of spine and other fractures compared to a placebo. This approval is especially important for patients who have not responded well to other osteoporosis treatments, such as bisphosphonates.

This approval gives doctors and patients a new anabolic option, meaning it helps build bone rather than just slowing bone loss. The safety and effectiveness were studied in postmenopausal women, with most women taking the drug for about 19 months. As with any medication, Forteo has potential side effects, and it is not for everyone.

If you or a loved one has osteoporosis, this news may be encouraging. However, it is important to talk to your doctor to see if Forteo is right for you. Your doctor can review your medical history, discuss risks and benefits, and help you make an informed decision. This approval does not mean that everyone with osteoporosis should take Forteo, but it provides another tool for those who need it.

What this means for you:

Forteo is a new bone-building drug for osteoporosis, but talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval

PublishedNov 2002

View Original Abstract ↓

1 INDICATIONS AND USAGE FORTEO 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, FORTEO 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. FORTEO is a parathyroid hormone analog, (PTH 1-34), indicated for: 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 ) Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy ( 1 ) Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy ( 1 )

FDA approved Forteo (teriparatide) for Osteoporosis TreatmentFDA approved new osteoporosis drug Forteo for high-risk patients

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