FRAX, a fracture risk assessment tool, was launched by the World Health Organization (WHO) in 2008.

It evaluates factors such as femoral neck bone mineral density (BMD), clinical risk factors, patient age, gender, fracture history, and steroid use.

Additionally, FRAX considers other clinical risk factors, including body mass index (BMI), parental history of hip fracture, rheumatoid arthritis, active smoking, alcohol consumption, and other medical conditions that contribute to bone loss.

The CAROC tool, developed in 2005 by the Canadian Association of Radiologists (CAR) and Osteoporosis Canada (OC), is used to assess 10-year fracture risk.

The approvals for these indications were based on the demonstrated similarity between Qosequ^MC and the reference biologic, PROLIA®.

Qosequ^MC (denosumab injection) is indicated for:

Postmenopausal Osteoporosis

• 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, Qosequ^MC reduces the incidence of vertebral, nonvertebral and hip fractures.

Treatment to Increase Bone Mass in Men with Osteoporosis at High Risk for Fracture

• As a 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.

Treatment to Increase Bone Mass in Men with Nonmetastatic Prostate Cancer receiving Androgen Deprivation Therapy (ADT), who are at high risk for fracture

• As a treatment to increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), who are at high risk for fracture.

Treatment to Increase Bone Mass in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Nonmetastatic Breast Cancer

• As a treatment to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy, who have low bone mass and are at high risk for fracture.

Treatment to Increase Bone Mass for the Treatment and Prevention of Glucocorticoid-Induced Osteoporosis in Women and Men at High Risk for Fracture

• As a treatment to increase bone mass in women and men at high risk for fracture due to sustained systemic glucocorticoid therapy.
• As a treatment to increase bone mass in women and men at high risk for fracture who are starting or have recently started long term glucocorticoid therapy.