Clinical trials help establish a medicine’s safety (side effects) and efficacy (how well that medicine works) in carefully controlled settings. Clinical trials may not represent what happens in real-world medical care or in the broader population living with the same disease.
In the Prolia® 3-Year fracture trial, women taking Prolia® for 3 years reduced their risk of new spine fractures by 68%. In this study of 7,393 patients, women not treated with Prolia® had more new spine fractures (7.2%) compared to women treated with Prolia® (2.3%).
After FDA approval, patients begin using the medication as part of their routine medical care. Researchers gather evidence from real-world situations, which differ from carefully controlled trials. This evidence is valuable for gaining a broader perspective on how the medication performs outside of a clinical trial. Evidence from a real-world study is meant to further our understanding of a medication, but is not meant to replace clinical trials.
In the largest real-world study of postmenopausal women with osteoporosis, the rate of fractures in women taking Prolia® was compared to the rate of fractures in women taking alendronate (commonly known as Fosamax). Information about fractures in these women was collected from January 2012-December 2019.
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Hear about the impact of Prolia® for real patients with postmenopausal osteoporosis at high risk for fracture.
What are the possible side effects of Prolia®?
It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.
The most common side effects of Prolia® in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).
The most common side effects of Prolia® in patients with corticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection (bronchitis), and headache.
The most common side effects of Prolia® in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and legs, and muscle pain. Additionally, in Prolia®-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.
These are not all the possible side effects of Prolia®. Call your doctor for medical advice about side effects.
Prolia® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
Prolia® is a prescription medicine used to increase bone mass in men with osteoporosis who are at high risk for fracture.
Prolia® is a prescription medicine used to treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six months and are at high risk for fracture.
Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
Prolia® is a prescription medicine used to treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.