Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Glucocorticoid use increases risk of spinal fractures

28.10.2002


Among postmenopausal women, glucocorticoid users six times more likely to fracture



Daily dosing with oral glucocorticoids (corticosteroids) for chronic diseases was found to be a strong predictor of spinal fracture at one year, according to new data presented at the annual scientific meeting of the American College of Rheumatology (ACR). The risk of fracture was found to increase incrementally with every 1 mg increase above 7.5 mg in the daily dose of the glucocorticoid.

Physicians frequently prescribe glucocorticoids to treat a variety of allergic and inflammatory diseases. Long-term (=3 months) use for chronic diseases is associated with a serious complication called glucocorticoid-induced osteoporosis (GIO).


"Osteoporotic fractures are typically associated with postmenopausal osteoporosis, but up to one half of patients on chronic glucocorticoid therapy may experience an osteoporotic fracture," said Tjeerd van Staa, MD, PhD, Department of Pharmacoepidemiology and Pharmacotherapy, University of Utrecht, the Netherlands and Drug Safety & Epidemiology, Procter & Gamble Pharmaceuticals – the presenting author of this study. "At one year, postmenopausal women using glucocorticoids were almost six times more likely to experience spinal fractures when compared to a group of postmenopausal women with low bone mineral density (BMD) who did not use glucocorticoids. This increased fracture risk is notable since the glucocorticoid patients were younger, had higher baseline BMD scores, and fewer pre-existing spinal fractures.

About GIO

In as little as three months, chronic use of steroids can cause significant bone loss, which could eventually lead to fracture.

The ACR guidelines recommend a class of drugs called bisphosphonates as first-line treatment for GIO in men and postmenopausal women initiating chronic glucocorticoid therapy (> 3 months duration), along with calcium, vitamin D and modification of lifestyle risk factors.

Actonel 5 mg daily is the only therapy approved by the U. S. Food and Drug Administration (FDA) for both the prevention and treatment of GIO in men and women who are initiating or continuing oral gluocorticoid treatment (? 7.5 mg/day prednisone or equivalent) for chronic diseases. In a combined analysis of two 1-year clinical studies in 518 patients initiating or continuing glucocorticoid therapy (>7.5 mg/d prednisone or equivalent) Actonel demonstrated a 70 percent reduction in vertebral fractures in just one year.

About the Study

The objective of this analysis was to evaluate the predictors and the BMD threshold for spinal fracture in oral glucocorticoid users. Data were obtained from two randomized clinical trials studying Actonel for the prevention and treatment of GIO (as described above).

The population analyzed consisted of 306 patients (both men and women) with a one-year spinal fracture assessment (111 placebo and 195 Actonel patients) and included 30 patients who experienced a new fracture in one year. In the placebo group, the statistically significant predictors for fracture were number of existing fractures and daily glucocorticoid dose. Subsequently, the effect of Actonel was analyzed in patients stratified by these risk factors. There was a trend shown with Actonel to reduce the risk of fracture versus placebo similarly regardless of whether patients did or did not have an existing fracture or whether the daily dose of corticosteroid was 7.5 to 15 mg or >15 mg.

In the BMD threshold analysis, the one-year fracture risk in postmenopausal placebo glucocorticoid users was compared to that of 2,570 postmenopausal women with low BMD not using glucocorticoids from four other Actonel trials. Although the glucocorticoid users were younger with higher baseline BMD and fewer pre-existing fractures compared to non-users, their risk of fracture was nearly six-fold higher.

This study was sponsored by The Alliance for Better Bone Health.

About Actonel ® (risedronate sodium tablets)

Actonel is co-developed and co-marketed by Procter & Gamble Pharmaceuticals and Aventis. Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (? 7.5 mg/d prednisone or equivalent) for chronic diseases.

In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.

In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and arthralgia (21.1 percent vs. 23.7 percent).

In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0 percent), arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent vs. 12.5 percent).

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis in May 1997 to develop and market Actonel collaboratively in Europe, the United States and Canada. The Alliance promotes bone health and disease awareness through numerous activities to support physicians and patients around the globe.

About Procter & Gamble

Procter & Gamble (P&G) is celebrating 165 years of providing trusted quality brands that make every day better for the world’s consumers. P&G markets nearly 300 brands in more than 160 countries around the world. The P&G community consists of nearly 102,000 employees working in almost 80 countries worldwide. P&G Pharmaceuticals is part of P&G’s Health Care global business unit. P&G Pharmaceuticals is focusing in the areas of endocrinology, cardiovascular and musculoskeletal diseases. Some of P&G’s leading prescription products include Actonel® (risedronate sodium tablets), Didronel® (etidronate disodium), Asacol® (mesalamine) and Macrobid® (nitrofurantoin monohydrate macrocrystals). Please visit www.pg.com for the latest news and in-depth information about P&G and its brands.

About Aventis

Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes, respiratory/allergy, anti-infectives as well as on human vaccines. In 2001, Aventis generated sales of € 17.7 billion ($15.8 billion), invested approx. € 3 billion ($2.7 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters is in Strasbourg, France. The company’s prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. Aventis Pharmaceuticals was recently named one of the top companies to work for by Working Mother magazine. For more information about Aventis in the U.S., please visit: www.aventis-us.com.

Please see full prescribing information for Actonel by visiting www.actonel.com. Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at http://www.pgpharma.com, the Aventis Pharmaceuticals U.S. Web site at http://www.aventispharmaus.com, or by calling 800/207-8049.

Lise Gelduldig, Mary Johnson | EurekAlert!
Further information:
http://www.pgpharma.com
http://www.aventispharmaus.com

More articles from Health and Medicine:

nachricht Norovirus evades immune system by hiding out in rare gut cells
12.10.2017 | University of Pennsylvania School of Medicine

nachricht Flexible sensors can detect movement in GI tract
11.10.2017 | Massachusetts Institute of Technology

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Neutron star merger directly observed for the first time

University of Maryland researchers contribute to historic detection of gravitational waves and light created by event

On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...

Im Focus: Breaking: the first light from two neutron stars merging

Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.

Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....

Im Focus: Smart sensors for efficient processes

Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).

When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...

Im Focus: Cold molecules on collision course

Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.

How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...

Im Focus: Shrinking the proton again!

Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.

It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ASEAN Member States discuss the future role of renewable energy

17.10.2017 | Event News

World Health Summit 2017: International experts set the course for the future of Global Health

10.10.2017 | Event News

Climate Engineering Conference 2017 Opens in Berlin

10.10.2017 | Event News

 
Latest News

Ocean atmosphere rife with microbes

17.10.2017 | Life Sciences

Neutrons observe vitamin B6-dependent enzyme activity useful for drug development

17.10.2017 | Life Sciences

NASA finds newly formed tropical storm lan over open waters

17.10.2017 | Earth Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>