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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 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. Close

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 study evaluating patients continuing on alendronate or transitioning to Prolia®

Objective1

This trial was conducted in postmenopausal women previously treated with alendronate to evaluate the effects of transitioning to Prolia® (denosumab) on safety, bone mineral density (BMD), and bone turnover markers (BTM) in comparison with continued alendronate therapy.

Background2,3

  • In clinical practice, approximately half of patients stop taking their osteoporosis medication within the first year and may require a switch to a different therapy
  • Prolia® targets and binds to RANK ligand, inhibiting osteoclast formation, function, and survival

Methods1

  • 1-year, multicenter, international, randomized, double-blind, double-dummy, parallel-group phase 3 trial
  • Adherence with oral study drug was evaluated at the end of the open-label run-in period and at months 1, 3, 6, 9, and 12 by counting tablets
  • Adverse events were recorded at each study visit with fractures being reported as adverse events

Endpoints1

The primary endpoint was the percent change in total hip BMD from baseline to month 12. Select secondary endpoints include percent change in BMD at lumbar spine at 12 months; safety endpoints included adverse events.

Key Inclusion Criteria1

  • Postmenopausal women with a BMD T-score of ≤ -2.0 and ≥ -4.0 at the lumbar spine or total hip
  • Patients must have been receiving alendronate 70 mg/week for ≥ 6 months prior to screening

Patients Continuing on Alendronate Therapy or Transitioning to Prolia® Were Evaluated

STAND adverse event profile

Overall, a similar number of participants in each treatment group reported adverse events during the study (78% Prolia®, 79% alendronate)1

SUMMARY OF ADVERSE EVENTS1

Alendronate (N = 249)
n (%)
Prolia® (denosumab) (N = 253)
n (%)
Any adverse event
196 (78.7)
197 (77.9)
Leading to study discontinuation
2 (0.8)
3 (1.2)
Death
0 (0.0)
1 (0.4)
Selected adverse events
Clinical fractures*
4 (1.6)
8 (3.2)
Gastrointestinal-related disorders
60 (24.1)
58 (22.9)
Infections
93 (37.3)
111 (43.9)
Neoplasms (benign or malignant)
9 (3.6)
9 (3.6)
Serious adverse events
16 (6.4)
15 (5.9)
Selected serious adverse events
Infections
3 (1.2)
1 (0.4)
Neoplasms (benign or malignant)
3 (1.2)
3 (1.2)

The most frequent adverse events in the denosumab and alendronate groups, respectively, were nasopharyngitis (13.4% and 10.8%), back pain (10.7% and 11.6%), bronchitis (6.3% and 5.6%), arthralgia (5.9% and 10.4%), constipation (5.1% and 4.8%), and pain in an extremity (4.7% and 8.4%).1

  • *On-study clinical fractures were as follows: Prolia®—2 foot, 2 wrist, 1 radius, 1 fibula, 1 humerus, 1 pelvis, 1 rib, 1 tibia; alendronate—1 foot, 1 wrist, 1 radius, 1 sacrum.

Patients who transitioned to Prolia® showed statistically significant changes in total hip and lumbar spine BMD1

  • Total Hip
  • Lumbar Spine

Increase in Total Hip BMD1*

0.85%
Increase
in BMD

The lower limit of the confidence interval excluded the prespecified non-inferiority margin (-0.35% for total hip), thus showing the non-inferiority of Prolia® compared with alendronate1

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 efficacy endpoint.
  • 95% CI 0.44% - 1.25%, p < 0.01.

Increase in Lumbar Spine BMD1

1.18%*
Increase
in BMD

The lower limit of the confidence interval excluded the prespecified non-inferiority margin (-0.22 for lumbar spine), thus showing the non-inferiority of Prolia® compared with alendronate1

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 0.63% - 1.73%, p < 0.01.