Efficacy | 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® delivers BMD gains to help you and your patients fight against glucocorticoid-induced osteoporosis (GIOP)1

In lumbar spine BMD, Prolia® demonstrated noninferiority and superiority at 12 months vs risedronate1

  • Initiating GC-therapy
  • Continuing GC-therapy

Initiating Glucocorticoid Therapy (GC-I)

Lumbar spine BMD increase. See references below.
  • Q6M = every 6 months; QD = every day; BMD = bone mineral density; BL = baseline.

Prolia® delivered significantly greater improvements in lumbar spine BMD as early as 6 months1

  • Percentage change from baseline in lumbar spine BMD with Prolia® vs risedronate in patients initiating (1.9% vs 0.5%) glucocorticoids1

Continuing Glucocorticoid Therapy (GC-C)

Lumbar spine BMD increase. See references below.
  • Q6M = every 6 months; QD = every day; BMD = bone mineral density; BL = baseline.

Prolia® delivered significantly greater improvements in lumbar spine BMD as early as 6 months1

  • Percentage change from baseline in lumbar spine BMD with Prolia® vs risedronate in patients continuing glucocorticoids (3.1% vs 2.0%)1
BMD data results are not meant to imply fracture efficacy and should not be extrapolated to predict differences in fracture efficacy. Head-to-head fracture studies have not been conducted.
  • *Primary endpoint.
  • (95% CI 1.4% - 3.0%), p < 0.001.
  • (95% CI 2.0% - 3.9%), p < 0.001.
  • Based on ANCOVA model adjusting for treatment, gender, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction; additionally, includes duration of prior glucocorticoid use (< 12 months vs ≥ 12 months) for GC-C subpopulation.

Phase 3 study design3

  • 2-year, randomized, multicenter, double-blind, parallel-group, active-controlled study. 795 patients aged 20 to 94 years were either initiating (GC-I) or continuing (GC-C) glucocorticoids 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)

Enrolled patients < age 503

  • were required to have a history of osteoporotic fracture

Enrolled patients ≥ age 503

  • who were in the GC-C subpopulation were required to have a baseline BMD T-score < -2.0 at the lumbar spine, total hip, or femoral neck; or a BMD T-score < -1.0 at the lumbar spine, total hip, or femoral neck and a history of osteoporotic fracture

Patients were randomized (1:1)3

  • to receive 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

Important Safety Information

Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia®. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue Prolia®.

Prolia® demonstrated superiority in total hip BMD at 12 months vs risedronate2

  • Initiating GC-therapy
  • Continuing GC-therapy

Initiating Glucocorticoid Therapy (GC-I)

Total hip BMD increase. See references below.
  • BL = baseline; BMD = bone mineral density.
  • Percentage change from baseline in total hip BMD vs risedronate (1.7% vs 0.2% in GC-I population; p < 0.001)1

Continuing Glucocorticoid Therapy (GC-C)

Total hip BMD increase. See references below.
  • BL = baseline; BMD = bone mineral density.
  • Percentage change from baseline in total hip BMD vs risedronate (2.1% vs 0.6% in GC-C population; p < 0.001)1
BMD data results are not meant to imply fracture efficacy and should not be extrapolated to predict differences in fracture efficacy. Head-to-head fracture studies have not been conducted.
  • *(95% CI 1.0% - 2.1%), p < 0.001.
  • *(95% CI 0.8% - 2.1%), p < 0.001.
  • Based on ANCOVA model adjusting for treatment, gender, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction; additionally, includes duration of prior glucocorticoid use (< 12 months vs ≥ 12 months) for GC-C subpopulation.