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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)

Guidance to ensure safe and effective physical activity for osteoporosis patients
Source: Bones / Orthopedics News From Medical News Today [2014.04.08]
Experts from the Too Fit to Fracture Initiative presented the results of an international consensus process to establish exercise recommendations for people with osteoporosis, with or without spine...

Early prevention of osteoporosis begins in youth
Source: Bones / Orthopedics News From Medical News Today [2014.04.07]
High levels of protein intake (HProt) enhance the positive impact of high physical activity (HPA) on bone structure and strength in healthy pre-pubertal boys, according to a study presented during...

Osteoporosis screening strategy using FRAX as pre-screening tool can be cost-effective
Source: Bones / Orthopedics News From Medical News Today [2014.04.06]
In new research presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, investigators showed that an osteoporosis screening strategy using FRAX as a...

Novel Osteoporosis Drug Could Change Treatment: Study
Source: MedicineNet alendronate Specialty [2014.01.03]
Title: Novel Osteoporosis Drug Could Change Treatment: Study
Category: Health News
Created: 1/2/2014 4:35:00 PM
Last Editorial Review: 1/3/2014 12:00:00 AM

Osteoporosis Drug Aids Young People With Cystic Fibrosis Not Helped By Standard Treatments
Source: Cystic Fibrosis News From Medical News Today [2013.06.06]
The first randomised trial to investigate the treatment of low bone density in young people with cystic fibrosis (CF), published Online First in The Lancet Respiratory Medicine, provides compelling...

more news >>

Published Studies Related to Prolia (Denosumab)

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

Infections in postmenopausal women with osteoporosis treated with denosumab or placebo: coincidence or causal association? [2012]
denosumab influences infection risk... CONCLUSIONS: Serious adverse events of infections that occurred with denosumab

Denosumab for the prevention of osteoporotic fractures in post-menopausal women: a NICE single technology appraisal. [2011.11.01]
The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of denosumab (Amgen Inc., UK) to submit evidence for the clinical and cost effectiveness of denosumab for the prevention of fragility fractures in post-menopausal women, as part of the Institute's single technology appraisal (STA) process...

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Clinical Trials Related to Prolia (Denosumab)

Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty [Recruiting]
Although hip replacement surgery is a successful way of dealing with the pain and immobility caused by hip arthritis, 10% of the hip replacements carried out in the UK fail within 10 years. The main reason for this is the development periprosthetic osteolysis, that is, loss of bone around the site of the hip replacement. The osteolysis is thought to be due to the small particles of debris worn from the surfaces of the hip implant. These particles cause a reaction in the blood cells around the joint which in turn affects bone cells and leads to a loss of bone around the implant. The joint implant will then eventually become loose and unstable, a condition known as aseptic loosening. At present the only way to treat aseptic loosening is to have another operation to secure the hip joint, known as revision surgery. Revision surgery is not always successful and exposes the patient to the risk of major surgery.

In this study we explore the potential for giving a medication (denosumab) that may prevent the loss of bone around the hip replacement implant. We will recruit patients who have been listed for revision surgery. One group of patients will be given a single dose of denosumabÍž another group will be given a placebo (dummy drug). At the time of the revision surgery a small sample of the bone from around the hip replacement will be taken and examined under the microscope. Comparisons will be made between the patients having the denosumab and those having placebo to find out whether the denosumab is having a beneficial effect on the bone surfaces. If successful, this study will lead to further studies to develop the use of denosumab to prevent aseptic loosening.

Denosumab in Primary Hyperparathyroidism [Recruiting]
Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone (PTH) and high blood calcium, is one of the most common endocrine disorders. PHPT is seen most often in postmenopausal women. Many patients with PHPT have low bone mineral density (BMD) when bone mass is measured by dual energy x-ray absorptiometry (DXA), primarily at the forearm. There is currently no effective medical therapy which increases bone density at the forearm in patients with PHPT.

PTH both builds and breaks down bone, and the pathways by which PTH mediates these actions are beginning to be identified. Prior research suggests that RANKL, a molecule important in bone metabolism, responds to PTH, and that if the RANKL is inactivated, PTH is shifted towards building bone. The investigators will study the effect of Denosumab, a therapeutic agent that binds to and inactivates RANKL, in 28 postmenopausal women with PHPT. Our hypothesis is that Denosumab will increase bone mineral density in primary hyperparathyroidism.

The study will last two years, and subjects will be randomly assigned to receive either placebo or Denosumab for the first year of the study. In the second year, all subjects will receive Denosumab. Denosumab (60 mg) or placebo will be given every 6 months by an injection just under the skin. Study procedures performed will include bone mineral density tests by DXA, high-resolution peripheral quantitative computed tomography (HR-pQCT) scans, and assessments of biochemical markers of calcium metabolism and bone turnover using both blood and urine samples of subjects with PHPT.

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

Anakinra or Denosumab and Everolimus in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the combination of Afinitor (everolimus) either with Kineret (anakinra) or Xgeva (denosumab) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.

Everolimus is designed to stop cells from dividing.

Anakinra is designated to block a protein that is involved in tumor development, new blood vessels growing, and spread of cancer.

Denosumab is designed to block the activity of a protein, which may prevent bone complications in cancer that has spread to the bone.

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: 2014-04-08

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