RxPG News : Pagets Disease

Single Infusion of Zoledronic Acid More Effective in Pagets Disease

Thu, 08 Sep 2005 01:07:38 PST

( from http://www.rxpgnews.com ) Pagets disease is the second most prevalent bone disease after osteoporosis. Affecting more than one million people, the chronic bone disorder is marked by the malfunction of the bodys regular bone building process and may result in pain, deformities and fractures.

This pooled analysis of two identical double-blind, active-controlled studies compared a single 15-minute infusion of zoledronic acid 5 mg solution to oral risedronate (30 mg per day for 60 days) in 357 patients with Pagets disease. At six months, nearly all patients receiving one dose of zoledronic acid 5 mg solution were effectively treated. Specifically, 96 percent of patients treated with zoledronic acid 5 mg solution responded compared to 74 percent of patients who received risedronate (p<0<0<0

Studies confirm new treatments for Paget's disease

Mon, 05 Sep 2005 23:55:38 PST

( from http://www.rxpgnews.com ) Two studies led by researchers at The University of Auckland's Faculty of Medical and Health Sciences have pioneered new, more effective treatment for two forms of Paget's disease - a chronic and often painful bone disease.

The results of the studies, one led by Professor Ian Reid, who heads the University's Bone Research Group, and the other by his colleague, Professor Tim Cundy have been published in separate articles in the latest edition of the prestigious New England Journal of Medicine.

Professor Reid led an international study which confirmed a new treatment for Paget's disease, giving a more rapid, effective and longer-lasting result than existing medication.

Professor Cundy's research focused on Juvenile Paget's disease, a rare genetic bone disease with some similarities to adult Paget's. Having earlier been involved in the identification of the genetic cause of the disease, he used an experimental new treatment that substantially relieved bone pain, improved bone density and reversed the metabolic abnormalities of the disease in two patients.

Paget's disease is the second most prevalent bone disease after osteoporosis and affects up to five percent of the older population in New Zealand. It is caused by a malfunction of the body's regular bone building process and results in bone pain, skeletal deformity, bone fractures, deafness and neurological complications. Generally onset is in people over the age of 40.

Juvenile Paget's disease, although very rare is very debilitating. It usually presents in infancy or childhood and results in progressive deformity, growth retardation and deafness.

"Paget's is very painful, affects mobility and can greatly affect the quality of life for sufferers, which is why new treatments are so worthwhile," Professor Reid says.

Professor Reid's international study pioneered the use of zoledronic acid, and showed that a single injection gave a rapid and long-lasting improvement in bone health.

"The new treatment quickly gives sufferers a much improved quality of life, and has a much lower rate of relapse than the conventional treatment."

A further benefit is that it is much easier on the patients - the conventional treatment with tablets requires patients to take daily oral medication in a strict daily regimen for up to six months.

The study involved nearly 360 patients from 10 countries around the world, including 15 from New Zealand.

Based on the results of the study, the new drug under the brand name, Aclasta, was licensed for treatment of Paget's disease in the European Union in April this year, Canada in June and is currently under regulatory review in the United States.

It has not yet been made available in New Zealand for Paget's disease.

Professor Cundy's patients were a brother and sister, who had been wheel-chair bound with Juvenile Paget's since they were 15. He used an experimental new treatment giving them recombinant osteoprotergerin, the protein that is lacking in sufferers and deficiency of which causes the condition.

"While the disease in these patients was too advanced for any treatment to correct deformity, it made enough of an improvement in their bones, and reduction in bone pain for us to believe it could be very useful in halting progress of the disease in infants and children."

European Commission Approves Zoledronic acid for the Treatment of Paget's Disease of Bone

Sun, 24 Apr 2005 08:12:38 PST

( from http://www.rxpgnews.com ) Novartis Pharma AG announced today that Aclasta® (zoledronic acid 5mg solution for infusion) has been granted Marketing Authorization by the European Commission for the treatment of Paget's disease of the bone in all 25 European member states, as well as Norway and Iceland. This represents the first approval for Aclasta.

In a head-to-head comparison versus the commonly used oral bisphosphonate risedronate, a single, 15 minute IV infusion of Aclasta showed superior efficacy1 and faster onset of action2, with longer remission following a single dose.3 Aclasta's unique molecular structure and IV administration enable fast and enduring efficacy.1 Aclasta, in clinical trials, was found to be generally safe and well tolerated.4

Bisphosphonates are well established as the standard of care for Paget's disease. However, oral risedronate requires daily administration for two months and for patients to avoid eating or drinking for 30 minutes prior to intake.5

"Oral bisphosphonates have limitations as not everyone responds well to them, or respond only very slowly and many relapse over time. In addition, they require complex administration regimens and are often associated with gastrointestinal discomfort, which can lead to poor compliance. The availability of a single intravenous infusion such as Aclasta that demonstrated superior efficacy, faster onset of action and longer remission in clinical studies compared to risedronate will be welcomed by patients and physicians," commented Professor Johann D Ringe, Klinikum Leverkusen, Germany. "Aclasta offers real benefits over oral bisphosphonates in the treatment of Paget's disease and resolves the issue of compliance."

"If you suffer from Paget's disease, you can't enjoy everyday activities such as tennis, walking or digging in the garden," added Dr. David Birch, who has been suffering from Paget's disease for 33 years. "The oral therapies currently available are associated with a lot of constraints."

In pivotal clinical studies, at six months, 96 percent of patients taking a single dose of Aclasta showed a therapeutic response, compared to 74 percent of patients taking 30 mg of risedronate, for 60 days.1 After more than 12 months, the vast majority of patients responding to Aclasta continued to maintain therapeutic response.3 At six months, serum alkaline phosphatase (SAP) levels - a key marker for bone turnover - were normal in 89 percent of Aclasta patients, compared with 58 percent of risedronate patients.1

Paget's disease, the second most common metabolic bone disease after osteoporosis6, can lead to serious consequences if not treated appropriately. It is a chronic skeletal disorder which in many patients causes pain, fractures and deformities that can seriously impede their ability to perform routine activities of daily living.7 This is a disease that can be difficult to diagnose, as not all patients experience noticeable symptoms7, leaving many untreated.

RxPG News : Pagets Disease

Single Infusion of Zoledronic Acid More Effective in Pagets Disease

Studies confirm new treatments for Paget's disease

European Commission Approves Zoledronic acid for the Treatment of Paget's Disease of Bone

Single Infusion of Zoledronic Acid More Effective in Pagets Disease