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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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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.

A head-to-head BMD study evaluating the effect of Prolia® or zoledronic acid after transitioning from an oral bisphosphonate1

Objective1

To compare the effect of transitioning from an oral bisphosphonate to denosumab or zoledronic acid on bone mineral density (BMD) and bone turnover markers (BTMs).

Background1

  • Osteoporosis is a chronic, progressive condition that generally requires long-term management

Methods1

  • 1-year, multicenter, international, randomized, double-blind, double-dummy, active-controlled, parallel-group trial
  • Subjects were randomized 1:1 to one of two treatment arms
  • Participants were required to take 1000 mg or greater elemental calcium and 800 IU or greater vitamin D daily

Key Inclusion Criteria1

  • Postmenopausal women aged 55 or older who received oral bisphosphonate therapy for ≥ 2 years
  • T-score of -2.5 or less at the lumbar spine, total hip, or femoral neck

Patients Transitioning to Prolia® or Zoledronic Acid Were Evaluated1

SC = subcutaneous; Q6M = every 6 months; IV = intravenous; Q12M = every 12 months.

Primary Endpoint1

  • Mean percent change from baseline in lumbar spine BMD at month 12

Select Additional Endpoints1

  • Mean percent change from baseline in total hip BMD
    at month 12
  • Safety endpoints for all subjects who received one or more doses of study drug

Statistical Analysis:1

  • The primary hypothesis was that treatment with denosumab was not inferior to zoledronic acid for the mean percentage change from baseline in lumbar spine BMD at month 12 based on a margin -0.46%
  • Secondary hypotheses included the following:
    1. noninferiority in total hip BMD with denosumab vs
      zoledronic acid based on a margin of -0.51%
    2. superiority of denosumab for the mean percentage
      change from baseline in lumbar spine BMD at month 12
    3. superiority of denosumab for the mean percentage
      change from baseline in total hip BMD at month 12
  • Only if the primary noninferiority hypothesis was demonstrated was the individual secondary hypothesis tested in the prespecified sequence

Prolia® demonstrated noninferiority and superiority (vs zoledronic acid) in lumbar spine and total hip BMD at 12 months1

  • Lumbar Spine
  • Total Hip

Increase in total hip BMD1

1.4% *
Increase
in BMD
  • Prolia® ( n = 321)
  • Zoledronic acid (n = 322)

This treatment difference of 1.4% at month 12 excluded the noninferiority margin of -0.51% and also achieved superiority (p < 0.0001).1

  • *(95% CI 1.0% - 1.7%), p < 0.0001 for noninferiority and superiority.
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.

Increase in lumbar spine BMD1,*

2.1%
Increase
in BMD
  • Prolia® ( n = 321)
  • Zoledronic acid (n = 322)

This treatment difference of 2.1% at month 12 excluded the predefined noninferiority margin of -0.46% and also achieved superiority (p < 0.0001).1

  • *Primary efficacy endpoint.
  • (95% CI 1.6% - 2.6%), p < 0.0001 for noninferiority and superiority.
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.

Adverse events in the study of patients transitioning to Prolia® or zoledronic acid1

Overall, a similar number of subjects in each treatment group reported adverse events during this head-to-head BMD study (62.2% in each treatment group)1

SUMMARY OF ADVERSE EVENTS1

Zoledronic Acid (N = 320)
n (%)
Prolia® (denosumab) (N = 320)
n (%)
All AEs
199 (62.2)
199 (62.2)
Serious AEs
29 (9.1)
25 (7.8)
AEs leading to discontinuation of study drug
9 (2.8)
4 (1.3)
Fatal AEs
1 (0.3)
0 (0.0)
Selected AEs of interest
Atypical femoral fracture
1 (0.3)
2 (0.6)
AEs potentially related to hypersensitivity
6 (1.9)
12 (3.8)
Serious infection
6 (1.9)
5 (1.6)
Malignancy
8 (2.5)
5 (1.6)
Cardiac disorders
4 (1.3)
11 (3.4)
Vascular disorders
16 (5.0)
13 (4.1)
Eczema*
1 (0.3)
5 (1.6)
Musculoskeletal pain
63 (19.7)
43 (13.4)
N = number of subjects who received one or more doses of study drug; n = number of subjects reporting one or more events.
  • *Events included eczema, dermatitis, and allergic dermatitis.