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Prolia (Denosumab) - Summary

 
 



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PROLIA SUMMARY

Prolia (denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand).

Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, as defined by factors such 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.
See all Prolia indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Prolia (Denosumab)

Study: Include men in osteoporosis screening guidelines
Source: Bones / Orthopedics News From Medical News Today [2015.05.21]
Osteoporosis affects more men than prostate cancerMost people associate osteoporosis with women.

Osteoporosis screening is too common for low-risk women and too uncommon for higher-risk women
Source: Bones / Orthopedics News From Medical News Today [2015.05.20]
Many of those who should get it, don't. And many of those who shouldn't, do.. That's the story of a common screening test for osteoporosis, according to new research from UC Davis Health System.

Men far less likely to prevent, screen for osteoporosis
Source: Bones / Orthopedics News From Medical News Today [2015.05.15]
Up to 2 million American men suffer from osteoporosis and another 8 to 13 million have low bone density, with worse health outcomes than womenWhile the consequences of osteoporosis are worse in...

Men Should Be Screened for Osteoporosis, Too
Source: MedicineNet Mens Health Specialty [2015.05.15]
Title: Men Should Be Screened for Osteoporosis, Too
Category: Health News
Created: 5/15/2015 12:00:00 AM
Last Editorial Review: 5/15/2015 12:00:00 AM

Weight-Loss Surgery and Women's Osteoporosis Risk
Source: MedicineNet Obesity (Weight Loss) Specialty [2015.05.13]
Title: Weight-Loss Surgery and Women's Osteoporosis Risk
Category: Health News
Created: 5/13/2015 12:00:00 AM
Last Editorial Review: 5/13/2015 12:00:00 AM

more news >>

Published Studies Related to Prolia (Denosumab)

Clinical Trials Express: fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis: denosumab fracture intervention randomized placebo controlled trial (DIRECT). [2014]
with osteoporosis compared with placebo... CONCLUSION: These results provide evidence of the efficacy and safety of

Delaying skeletal-related events in a randomized phase 3 study of denosumab versus zoledronic acid in patients with advanced cancer: an analysis of data from patients with solid tumors. [2014]
myeloma... CONCLUSIONS: Denosumab was more effective in delaying or preventing SREs in

Superiority of denosumab to zoledronic acid for prevention of skeletal-related events: a combined analysis of 3 pivotal, randomised, phase 3 trials. [2012]
across three pivotal studies... CONCLUSION: Denosumab was superior to zoledronic acid in preventing SRE with

Responder analysis of the effects of denosumab on bone mineral density in men receiving androgen deprivation therapy for prostate cancer. [2012]
(lumbar spine (LS), femoral neck (FN) and total hip (TH)) and the distal radius... CONCLUSIONS: In men with prostate cancer receiving ADT, significantly higher BMD

Dose-response study of denosumab on bone mineral density and bone turnover markers in Japanese postmenopausal women with osteoporosis. [2012]
12 months in Japanese postmenopausal women with osteoporosis... CONCLUSIONS: Denosumab 60 mg could be an effective dose for Japanese

more studies >>

Clinical Trials Related to Prolia (Denosumab)

Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo [Recruiting]
The etiology of bone marrow edema (BME) is still uncertain. Several studies report therapeutic success with antiresorptive drugs.

This study investigates antiresorptive and osteoanabolic drugs versus placebo in BME

Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients [Recruiting]
The primary objective of the study is to examine the effect of denosumab on total hip bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the lumbar spine and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality.

- Trial with medicinal product

Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis - The ADAMO Trial [Recruiting]
The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture. The primary clinical hypothesis is that in men with low bone mineral density, the mean percent change in lumbar spine bone mineral density at 12 months in subjects receiving denosumab will be greater than in subjects receiving placebo. Denosumab is a fully human monoclonal antibody with a high affinity for Receptor Activator of Nuclear Factor-kB (RANK) Ligand that can bind and neutralize the activity of human RANK Ligand similar to the action of endogenous osteoprotegerin.

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium [Recruiting]
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium
more trials >>

Reports of Suspected Prolia (Denosumab) Side Effects

Pain in Extremity (348)Back Pain (330)Arthralgia (289)Rash (223)Pain (212)Myalgia (197)Osteonecrosis of JAW (169)Bone Pain (161)Pruritus (160)Hypocalcaemia (146)more >>


Page last updated: 2015-05-21

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