FDA approved Jubbonti (denosumab) for Osteoporosis and Bone Loss IndicationsFDA approved Jubbonti, a Twice-Yearly Shot for Weak Bones

FDA From the archive Source published March 5, 2024 Summary added October 28, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note: rule out pregnancy before Jubbonti and ensure calcium plus vitamin D in all patients.

The FDA has approved Jubbonti (denosumab), a RANK ligand (RANKL) inhibitor, for five bone health indications: treatment of postmenopausal women with osteoporosis at high risk for fracture; increasing bone mass in men with osteoporosis at high risk for fracture; treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Jubbonti is administered by a healthcare provider as a 60 mg subcutaneous injection every 6 months in the upper arm, upper thigh, or abdomen. Pregnancy must be ruled out before administration in females of reproductive potential, and all patients should receive calcium 1000 mg daily plus at least 400 IU vitamin D daily. In patients with advanced chronic kidney disease, including dialysis patients, the label directs evaluation for chronic kidney disease mineral and bone disorder before treatment decisions.

For clinicians managing patients at high fracture risk, the approval adds a twice-yearly injectable RANKL inhibitor option across osteoporosis and cancer treatment-related bone loss settings. Trial data are not available in the label.

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

Mechanism of Action

Jubbonti is a RANK ligand (RANKL) inhibitor. The label does not provide further mechanistic detail beyond this classification.

Indication & Patient Population

Jubbonti is indicated for: treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy; treatment to increase bone mass in men with osteoporosis at high risk for fracture, similarly defined; treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are initiating or continuing systemic glucocorticoids at a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months; treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Dosing & Administration

Pregnancy must be ruled out before administration. In patients with advanced chronic kidney disease, including dialysis patients, evaluate for chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25(OH)2 vitamin D before treatment decisions. Jubbonti should be administered by a healthcare provider at 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. If a dose is missed, administer as soon as the patient is available, then schedule injections every 6 months from the date of the last injection. Inspect visually before administration; do not use if discolored, cloudy, or containing visible particles. The product may be brought to room temperature by standing in the original container for 15 to 30 minutes; do not warm in any other way.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Based on animal findings, denosumab products can cause fetal harm when administered to pregnant women; pregnancy testing is required in all females of reproductive potential before administration. In patients with advanced chronic kidney disease, including dialysis-dependent patients, evaluate for chronic kidney disease mineral and bone disorder before decisions regarding treatment. The label cross-references Warnings and Precautions regarding hypocalcemia and calcium/vitamin D supplementation. Full contraindications are not detailed in the provided label text.

Place in Therapy

Jubbonti offers a twice-yearly subcutaneous RANKL inhibitor administered by a healthcare provider for patients with osteoporosis at high fracture risk and for bone loss associated with androgen deprivation or aromatase inhibitor therapy. The label defines high risk by fracture history, multiple risk factors, or failure or intolerance of other osteoporosis therapy. Calcium and vitamin D supplementation are required for all patients.

The FDA has approved a new drug called Jubbonti, also known by its generic name denosumab. It is a shot given by a healthcare provider every six months. The drug helps strengthen bones and lower the chance of broken bones in people at high risk.

Jubbonti is approved for several groups. These include women after menopause with osteoporosis, men with osteoporosis, and people whose bones have weakened from steroid medicines. It is also for men receiving certain hormone treatment for prostate cancer and women receiving certain hormone treatment for breast cancer.

For patients and families, this approval means another treatment choice for protecting bones. It is given as a shot in the arm, thigh, or belly, so patients do not need to give it to themselves at home. Patients also take calcium and vitamin D each day, and women who could become pregnant must first have pregnancy ruled out.

One honest caveat: this is a decision to make with your doctor. Your doctor can explain whether Jubbonti fits your health, your other medicines, and your kidney health. This news does not mean everyone should switch treatments. Ask questions and talk through your options together.

What this means for you:

A new twice-yearly bone shot is approved, but ask your doctor if it fits your health.

Study Details

Study typeFda approval

PublishedMar 2024

View Original Abstract ↓

1 INDICATIONS AND USAGE Jubbonti is a RANK ligand (RANKL) inhibitor indicated for treatment: • of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) • to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) • of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. ( 1.3 ) • to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) • to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Jubbonti is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )] . 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Jubbonti is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.2 )] . 1.3 Treatment of Glucocorticoid-Induced Osteoporosis Jubbonti is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies ( 14.3 )] . 1.4 Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Jubbonti is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients denosumab also reduced the incidence of vertebral fractures [see Clinical Studies ( 14.4 )] . 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Jubbonti is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer [see Clinical Studies ( 14.5 )] .

FDA approved Jubbonti (denosumab) for Osteoporosis and Bone Loss IndicationsFDA approved Jubbonti, a Twice-Yearly Shot for Weak Bones

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