Safety Data | Glucocorticoid-induced Osteoporosis | Prolia® (denosumab)
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Indications

Prolia® 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 Read More

Prolia® 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, Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures.

Prolia® 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.

Prolia® 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.

Prolia® is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.

Prolia® is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

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For the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture

Prolia® safety profile in patients with glucocorticoid-induced osteoporosis (GIOP)1

The incidence of serious adverse events was similar for both Prolia® and risedronate groups (16% vs 17%)1

Adverse Reactions in ≥ 2% of Patients With Glucocorticoid-induced Osteoporosis and More Frequently with Prolia®1
 
Risedronate (N = 384) n (%)
Prolia® (denosumab) (N = 394) n (%)
Most common adverse events
 
 
Back pain
17 (4.4)
18 (4.6)
Hypertension
13 (3.4)
15 (3.8)
Bronchitis
11 (2.9)
15 (3.8)
Headache
7 (1.8)
14 (3.6)
Dyspepsia
10 (2.6)
12 (3.0)
Urinary tract infection
8 (2.1)
12 (3.0)
Abdominal pain, upper
7 (1.8)
12 (3.0)
Upper respiratory tract infection
10 (2.6)
11 (2.8)
Constipation
6 (1.6)
11 (2.8)
Vomiting
6 (1.6)
10 (2.5)
Dizziness
8 (2.1)
9 (2.3)
Fall
7 (1.8)
8 (2.0)
Polymyalgia rheumatica*
1 (0.3)
8 (2.0)
  • *Events of worsening of underlying polymyalgia rheumatica.
  • Osteonecrosis of the Jaw (ONJ): No cases of ONJ were reported1
  • Atypical Femoral Fractures (AFF): AFF were reported in 1 patient treated with Prolia®. The duration of Prolia® exposure to time of AFF diagnosis was at 8.0 months1
  • Serious Infections: Serious infections were reported in 15 patients (3.9%) in the active-control group and 17 patients (4.3%) in the Prolia® group1
  • Dermatologic Reactions: Epidermal and dermal adverse events (such as dermatitis, eczema, and rashes) were reported in 16 patients (4.2%) in the active-control group and 15 patients (3.8%) in the Prolia® group1