Media Articles Related to Prolia (Denosumab)
Health Tip: Know the Risk Factors for Osteoporosis
Source: MedicineNet Osteoporosis Specialty [2014.10.14]
Title: Health Tip: Know the Risk Factors for Osteoporosis
Category: Health News
Created: 10/14/2014 12:00:00 AM
Last Editorial Review: 10/14/2014 12:00:00 AM
Men not being adequately diagnosed or treated for osteoporosis: hip fracture twice as likely to kill men compared to women
Source: Bones / Orthopedics News From Medical News Today [2014.10.11]
Alarming new data just published by the International Osteoporosis Foundation (IOF), shows that one-third of all hip fractures worldwide occur in men, with mortality rates as high as 37% in the first...
'Unsung' cells double the benefits of a new osteoporosis drug
Source: Bones / Orthopedics News From Medical News Today [2014.10.07]
Experiments in mice with a bone disorder similar to that in women after menopause show that a scientifically overlooked group of cells are likely crucial to the process of bone loss caused by the...
Breast cancer patients who receive osteoporosis treatment may benefit from protective effect on bone metastasis
Source: Bones / Orthopedics News From Medical News Today [2014.10.07]
Treatment approaches to reduce the risk of bone complications (metastasis) associated with breast cancer may be one step closer to becoming a reality.
Osteoporosis: bone health in childhood 'is an important factor'
Source: Bones / Orthopedics News From Medical News Today [2014.09.29]
The American Academy of Pediatrics have reviewed bone acquisition in childhood to advise pediatricians on bone health strategies for young patients.
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. 
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. 
(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. 
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? 
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...
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
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.
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
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
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.
Reports of Suspected Prolia (Denosumab) Side Effects
Pain in Extremity (348),
Back Pain (330),
Osteonecrosis of JAW (169),
Bone Pain (161),
Hypocalcaemia (146), more >>