Prolia vs Bisphosphonates | Osteoporosis Treatment | Amgen

IN HEAD-TO-HEAD STUDIES, PROLIA® SHOWS SUPERIOR BMD IMPROVEMENTS COMPARED WITH BISPHOSPHONATES1–4

Superior increases in BMD are observed at 12 months in patients who transition to Prolia® from an oral bisphosphonate, compared with those who remain on or transition to bisphosphonates.1–4
Prolia® has also shown superior increases in BMD in treatment-naïve patients vs alendronate.5
Data are from an international, multicentre, randomized trial of postmenopausal women with osteoporosis who had previously been prescribed alendronate therapy for at least 6 months. Patients continued to receive open-label branded alendronate 70 mg every week or subcutaneous Prolia® 60 mg every 6 months for 12 months. Data are least-squares means (95% confidence intervals).1
*p<0.0001.
p<0.0125
Data are from an international, multicentre, randomized trial of postmenopausal women with osteoporosis previously treated with oral bisphosphonates. Patients were randomized to receive subcutaneous 60 mg Prolia® every 6 months plus intravenous placebo once for 12 months, or subcutaneous placebo every 6 months plus 5 mg intravenous zoledronic acid once for 12 months. Data represent least-squares means and 95% confidence intervals based on an ANCOVA model adjusting for treatment; serum CTx stratification variable (300 pg/mL vs. 300–500 pg/mL), baseline BMD, DXA machine type, and baseline value by machine-type interaction.2
*p<0.0001 for non-inferiority.
p<0.0001 for superiority.
ǂp=0.018 for superiority.
Data are from a randomized, open-label, parallel-group trial of postmenopausal women with low bone mineral density who had been treated previously with oral bisphosphonates. Patients were randomized to receive either subcutaneous 60 mg Prolia® every 6 months or 150 mg ibandronate orally every month for 12 months. At the lumbar spine, 398 Prolia® and 372 ibandronate were analyzed. Data are least-squares means (95% confidence intervals).3
*p<0.001.
Data are from a randomized, open-label, parallel-group trial of postmenopausal women with low bone mineral density who had been treated previously with alendronate, but had either stopped therapy or were still taking alendronate but demonstrating suboptimal adherence. Patients received either subcutaneous 60 mg Prolia® every 6 months or 150 mg risedronate orally every month for 12 months. Data are least-squares means (95% confidence intervals).4
*p<0.0001.
Click here to discover how Prolia® is associated with higher rates of clinically meaningful gains in BMD compared with placebo and bisphosphonates.
BMD also improved with Prolia® compared to placebo in women undergoing therapy for non-metastatic breast cancer and men with non-metastatic prostate cancer.6,7

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The use of aromatase inhibitor therapy in breast cancer patients is often associated with bone loss. Prolia® over a time period of 2 years resulted in consistent increases in BMD compared to placebo; regardless of the type and duration of aromatase inhibitor given, or skeletal site measured.6
A study in men with histologically confirmed non-metastatic prostate cancer and a history of osteoporotic fracture showed that, compared to placebo, Prolia® significantly increased BMD at all skeletal sites studied (femoral neck, lumbar spine, total hip and distal radius) after 3 years of treatment and was associated with a reduction in vertebral fractures as early as 1 year.7

References:
BMD: bone mineral density; CTx: C-terminal telopeptide of type 1 collagen; DXA: dual X-ray absorptiometry.
  1. Kendler DL, et al. J Bone Miner Res. 2010;25:72–81.
  2. Miller PD, et al. J Clin Endocrinol Metab. 2016;101:3163–70.
  3. Recknor C, et al. Obstet Gynecol. 2013;121:1291–9.
  4. Roux C, et al. Bone. 2014;58:48–54.
  5. Brown JP, et al. J Bone Miner Res. 2009;24:153–61.
  6. Ellis GK, et al. Breast Cancer Res Treat. 2009;118:81–7.
  7. Egerdie RB, et al. Prostate Cancer Prostatic Dis. 2012;15:308–12.

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