Prolia (Denosumab) - Summary

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.

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NEWS HIGHLIGHTS

Media Articles Related to Prolia (Denosumab)

Osteoporosis Quiz: What is Osteoporosis?
Source: MedicineNet Hormone Therapy Specialty [2017.09.19]
Title: Osteoporosis Quiz: What is Osteoporosis?
Category: MedicineNet Quiz
Created: 1/14/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 5:17:33 PM

Osteoporosis
Source: MedicineNet Ehlers-Danlos Syndrome Specialty [2017.02.02]
Title: Osteoporosis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 2/2/2017 12:00:00 AM

What Is Osteoporosis? Treatment, Symptoms, Medication
Source: MedicineNet calcium carbonate Specialty [2016.07.28]
Title: What Is Osteoporosis? Treatment, Symptoms, Medication
Category: Slideshows
Created: 4/23/2009 12:00:00 AM
Last Editorial Review: 7/28/2016 12:00:00 AM

Osteoporosis Super-Foods for Strong Bones With Pictures
Source: MedicineNet risedronate Specialty [2016.06.10]
Title: Osteoporosis Super-Foods for Strong Bones With Pictures
Category: Slideshows
Created: 2/3/2009 12:00:00 AM
Last Editorial Review: 6/10/2016 12:00:00 AM

Vertebral Fractures Frequently Underreported by Radiologists
Source: Medscape Anesthesiology Headlines [2017.09.26]
Vertebral fractures are largely underreported by radiologists, missing an opportunity for patients to be treated for osteoporosis and prevent further fracture.
Medscape Medical News

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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

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Clinical Trials Related to Prolia (Denosumab)

Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Prolia� in Routine Clinical Practice [Completed]
The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with Prolia® (denosumab) in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.

Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia� in France [Recruiting]
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France

Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density [Completed]
To determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density (BMD) of the lumbar spine in postmenopausal women with low BMD. The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated.

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 denosumab; 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.

A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral Density [Completed]
The purpose of this study is to compare the immunogenicity profiles of denosumab pre-filled syringe (PFS) and vial at 6 months in postmenopausal women with low bone mineral density (BMD).

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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 >>