Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Data show bone mineral density explains only small portion of nonvertebral fracture risk reduction

20.06.2003


A new analysis showed that increases in bone mineral density (BMD) only accounted for 6 to 12 percent of the reduction in non-vertebral fracture risk that resulted from osteoporosis treatment over three years in postmenopausal women.

Previously, analyses of clinical trial data for three major osteoporosis therapies have shown that increases in BMD account for only a fraction (<1/3) of the total reduction in vertebral fracture risk. These new findings, presented today at ENDO 2003, the 85th annual meeting of The Endocrine Society, support that this is also the case for fractures at nonvertebral sites, such as the hip and wrist.

BMD measurement remains a good tool for evaluating patients who are not on treatment and for identifying patients on treatment who are not responding; however, BMD increases in response to therapy cannot replace fracture reduction as the ultimate goal of osteoporosis therapies and the most clinically relevant endpoint. Although BMD is often used as a surrogate marker of efficacy, this study provides further confirmation that BMD is only one of many factors that contribute to the efficacy of an osteoporosis therapy. "These results underscore the importance of physicians evaluating osteoporosis therapies based upon fracture reduction data," said Nelson B. Watts, MD, presenting author and Director, University of Cincinnati Bone Health and Osteoporosis Center. "Many factors of bone quality are important for strong bones, such as rate of bone turnover, bone microarchitecture, and material properties of bone. Therefore, BMD should not be used to compare fracture efficacy between osteoporosis therapies."



Analysis Details

This analysis was conducted with data from two pivotal trials that supported the approval of ActonelŽ(risedronate sodium tablets) for the prevention and treatment of postmenopausal osteoporosis. The trials included over 3,600 women who were enrolled on the basis of low lumbar spine BMD (T-score < -2.0) and at least one prevalent vertebral fracture OR at least two prevalent vertebral fractures. Patients were randomized to receive either Actonel 5 mg daily or placebo. All patients received 1,000 mg daily calcium, and, if baseline levels were low, up to 500 IU daily vitamin D. Nonvertebral fractures were defined as a composite endpoint from fractures of the clavicle, upper arm, forearm, pelvis, hip, and lower leg.

The reduction in nonvertebral fracture risk in the Actonel patients was estimated to be 35 percent over 3 years. The average increase in BMD for these patients was 4.6 percent at lumbar spine and 2.6 percent at femoral neck. The BMD increases at the lumbar spine accounted for only 12.2 percent of the nonvertebral fracture risk reduction, and the BMD increases at the femoral neck accounted for only 5.5 percent of the nonvertebral fracture risk reduction.

About Osteoporosis

Osteoporosis is a skeletal disorder characterized by reduced bone strength predisposing a person to an increased risk of fracture. According to the National Osteoporosis Foundation, 1.2 million women suffer osteoporotic fractures in the U.S. each year. Risk factors for osteoporosis and subsequent fractures include loss of estrogen production, advanced age, preexisting fractures, and low bone mineral density. Studies show that among postmenopausal women with osteoporosis who experience a spinal fracture, one out of five will suffer their next spinal fracture within just one year, potentially leading to a fracture cascade.

Preventive measures, such as not smoking, maintaining a balanced diet supplemented with calcium and vitamin D, and engaging in weight-bearing exercise like walking, can reduce an individual’s chances of developing osteoporosis. However, in some people these preventive measures may not be enough, and medications like Actonel may be beneficial.

About ActonelŽ (risedronate sodium tablets)

Actonel was developed by Procter & Gamble Pharmaceuticals and is co-marketed by Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals. 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 (greater than or equal to 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).

Contact: Molly Fahner, molly.fahner@hillandknowlton.com

Molly Fahner | EurekAlert!
Further information:
http://www.actonel.com
http://www.hillandknowlton.com

More articles from Health and Medicine:

nachricht New malaria analysis method reveals disease severity in minutes
14.08.2017 | University of British Columbia

nachricht New type of blood cells work as indicators of autoimmunity
14.08.2017 | Instituto de Medicina Molecular

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: Fizzy soda water could be key to clean manufacture of flat wonder material: Graphene

Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.

As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...

Im Focus: Exotic quantum states made from light: Physicists create optical “wells” for a super-photon

Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.

Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...

Im Focus: Circular RNA linked to brain function

For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.

While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...

Im Focus: RAVAN CubeSat measures Earth's outgoing energy

An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.

The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...

Im Focus: Scientists shine new light on the “other high temperature superconductor”

A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.

Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Call for Papers – ICNFT 2018, 5th International Conference on New Forming Technology

16.08.2017 | Event News

Sustainability is the business model of tomorrow

04.08.2017 | Event News

Clash of Realities 2017: Registration now open. International Conference at TH Köln

26.07.2017 | Event News

 
Latest News

Gold shines through properties of nano biosensors

17.08.2017 | Physics and Astronomy

Greenland ice flow likely to speed up: New data assert glaciers move over sediment, which gets more slippery as it gets wetter

17.08.2017 | Earth Sciences

Mars 2020 mission to use smart methods to seek signs of past life

17.08.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>