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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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A phase III study evaluated fracture risk in over 3400 women with nonmetastatic breast cancer1

The Adjuvant Denosumab in Breast Cancer (ABCSG-18) trial: The largest study and longest follow-up evaluating fracture risk in postmenopausal* women receiving AI therapy for nonmetastatic breast cancer1

Study Design
Patients were randomized to receive either:
  • -Denosumab 60 mg (n=1711) subcutaneously every 6 months
  • -Placebo (n=1709) subcutaneously every 6 months
Daily supplements of 500-mg calcium and ≥400 IU vitamin D were recommended throughout study treatment
PRIMARY ENDPOINT
  • -Time to first clinical fracture
SECONDARY ENDPOINTS
  • -Percentage change in BMD in the total lumbar spine, total hip, and femoral neck and new or worsening fractures in patients from baseline to 36 months
  • -New vertebral fractures from baseline to 36 months
  • -New or worsening of pre-existing vertebral fractures from baseline to 36 months
EXPLORATORY ENDPOINTS
  • -Percentage change in BMD in the total lumbar spine, total hip, and femoral neck and new or worsening fractures in patients from baseline to 12 and 24 months
  • *Women were considered postmenopausal if they had a bilateral oophorectomy, were > 60 years old, or were < 60 years old but had follicle-stimulating hormone (FSH) and estradiol levels in the postmenopausal range.
  • Clinically evident fractures—excluding the skull, face, fingers, and toes—with associated symptoms.

ABCSG-18 was the first major study to evaluate high-risk postmenopausal women with a wide range of baseline characteristics, including T-scores, age, and tumor grades1

Baseline demographics between treatment groups1
Prolia® 60 mg
every 6 months
(n=1711)
Placebo every 6
months (n=1709)
Age group (years)
<50
34 (2%)
31 (2%)
50-59
473 (28%)
448 (26%)
60-69
782 (46%)
755 (44%)
70-79
372 (22%)
414 (24%)
≥80
50 (3%)
61 (4%)
Tumor grade
G1
365 (21%)
338 (20%)
G2/Gx
1038 (61%)
1028 (60%)
G3
303 (18%)
339 (20%)
Unknown
5 (<1%)
4 (<1%)
Chemotherapy before randomization
None
1288 (75%)
1287 (75%)
Adjuvant
338 (20%)
329 (19%)
Neoadjuvant
85 (5%)
93 (5%)
Start of AI treatment
With denosumab/placebo
270 (16%)
269 (16%)
Before denosumab/placebo
1441 (84%)
1440 (84%)
Total lumbar spine BMD
T-score <-1.0
773 (45%)
775 (45%)
T-score ≥-1.0
938 (55%)
934 (55%)
  • The protocol allowed administration of AI for up to 2 years prior to randomization. Median duration of AI therapy before randomization in 2881 patients was 1 month.