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

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Key Takeaway
Consider teriparatide for high-risk osteoporosis patients, but limit use to 2 years and monitor for orthostatic hypotension.

The FDA has approved Bonsity (teriparatide) for the treatment of osteoporosis in postmenopausal women at high risk for fracture, to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, and for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy. The approval provides an additional option for patients who have failed or are intolerant to other available osteoporosis therapies.

Teriparatide is a parathyroid hormone analog (PTH 1-34) that stimulates bone formation. In a pivotal clinical trial of postmenopausal women with osteoporosis, teriparatide reduced the risk of new vertebral fractures by 65% and nonvertebral fractures by 53% compared with placebo, when both groups received calcium and vitamin D. The recommended dose is 20 mcg subcutaneously once daily, with treatment duration limited to 2 years over a patient's lifetime.

Clinicians should consider Bonsity for patients at high risk for fracture, including those with a history of osteoporotic fracture or multiple risk factors. The drug is administered subcutaneously into the thigh or abdominal region, and patients should be monitored for orthostatic hypotension, particularly at the start of therapy.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Teriparatide is a parathyroid hormone analog (PTH 1-34) that stimulates bone formation. The exact mechanism is not fully described in the label, but it is known to increase bone mass and reduce fracture risk.

Indication & Patient Population

Teriparatide injection 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. It 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 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.

Key Clinical Trial Data

In a double-blind, multicenter, placebo-controlled study of 1637 postmenopausal women with osteoporosis (median exposure 19 months), 541 women received teriparatide 20 mcg subcutaneously once daily. All women received 1000 mg calcium and at least 400 IU vitamin D daily. The primary endpoint was new vertebral fractures. Teriparatide reduced the risk of new vertebral fractures from 14.3% in the placebo group to 5.0% in the teriparatide group (p <0.001), an absolute risk reduction of 9.3% and relative risk reduction of 65%. Teriparatide 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

Specific warnings and contraindications are not detailed in the provided label text. However, the label references Warnings and Precautions sections (5.1 and 5.4) regarding treatment duration and orthostatic hypotension. Clinicians should refer to the full prescribing information for complete safety information.

Place in Therapy

Teriparatide injection is indicated for patients at high risk for fracture, including those who have failed or are intolerant to other osteoporosis therapies. It is an anabolic agent that reduces vertebral and nonvertebral fractures in postmenopausal women. Treatment duration is limited to 2 years over a patient's lifetime.

The U.S. Food and Drug Administration has approved a new drug called Bonsity (teriparatide) for the treatment of osteoporosis. Osteoporosis is a condition that makes bones weak and more likely to break. Bonsity is approved for postmenopausal women at high risk for fractures, for men with primary or hypogonadal osteoporosis at high risk for fractures, and for men and women with osteoporosis caused by long-term use of steroid medicines. It is meant for people who have not responded well to or cannot tolerate other osteoporosis treatments.

Bonsity is a form of parathyroid hormone that helps the body build new bone. In a key study of postmenopausal women, Bonsity reduced the risk of new spine fractures by 65% and other fractures by 53% compared to a placebo, when both groups took calcium and vitamin D. The recommended dose is 20 micrograms injected under the skin once a day, and treatment should not last more than two years over a person's lifetime.

This approval gives patients and doctors another option to help prevent fractures. However, it is not for everyone. Doctors should consider Bonsity for patients at high risk for fracture, such as those who have already had a fracture or have multiple risk factors. Patients will need to learn how to inject the medicine and should be watched for low blood pressure when standing up, especially when starting treatment.

If you have osteoporosis, talk to your doctor about whether Bonsity might be right for you. This approval does not mean it is the best choice for everyone, and you should not stop or change any current treatment without medical advice.

What this means for you:
Bonsity is a new option for osteoporosis, but talk to your doctor to see if it's right for you.

Study Details

Study typeFda approval
PublishedOct 2019
View Original Abstract ↓
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. Teriparatide injection 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 )
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