Study Design | 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® has been evaluated in a head-to-head BMD study of patients with glucocorticoid-induced osteoporosis (GIOP)1

12-Month Primary Analysis (N = 795)2

Schematic of 12-month Primary Analysis. See references below.
  • SC = subcutaneous; Q6M = every 6 months; PO = by mouth; QD = every day.

Study Design3

  • 2-year, randomized, multicenter, double-blind, parallel-group, active-controlled study
  • 795 patients (70% women and 30% men) aged 20 to 94 years (mean age of 63.1 years)

Treatment Subpopulations2

  • Patients were either initiating (GC-I) or continuing (GC-C) glucocorticoid treatment with ≥ 7.5 mg/day oral prednisone (or equivalent):
    • GC-I subpopulation: < 3 months prior to study enrollment and planning to continue glucocorticoids for a total of at least 6 months (n = 290)
    • GC-C subpopulation: ≥ 3 months prior to study enrollment and planning to continue glucocorticoids for a total of at least 6 months (n = 505)
  • Some patients were also taking biologic or nonbiologic immunosuppressants

Inclusion Criteria2

  • Between 18 and 50 years of age with a history of osteoporotic fracture, or
  • ≥ 50 years of age (in the GC-C subpopulation) with a baseline BMD T-score of:
    • < -2.0 at the lumbar spine, total hip, or femoral neck, or
    • < -1.0 at the lumbar spine, total hip, or femoral neck and a history of osteoporotic fracture

Patient Randomization (1:1)2

  • Either an oral daily bisphosphonate (active control, risedronate 5 mg once daily) (n = 397), or
  • Prolia® 60 mg subcutaneously once every 6 months (n = 398) for one year
  • All patients were supplemented with daily calcium and vitamin D
Primary Endpoint:

Noninferiority to risedronate for percent change from baseline in lumbar spine BMD at 12 months3

Select Secondary
Endpoints:

Superiority over risedronate for percent change from baseline in lumbar spine and total hip BMD at 12 months3

Select Exploratory
Endpoint:

Percent change in lumbar spine BMD at 6 months3