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November 9, 2010

Long-term data show Novartis once-yearly osteoporosis drug preserves bone mass and provides fracture protection in postmenopausal osteoporosis

  • Zoledronic acid 5 mg reduced the risk of new spine fractures by 52% over six years versus patients who stopped treatment after three years1.
  • New data from six-year study validate zoledronic acid 5 mg safety profile and support long-term use of annual infusions in patients with postmenopausal osteoporosis1.
  • More than one million zoledronic acid 5 mg infusions administered worldwide2 for the treatment of early to advanced bone loss3.
  • Zoledronic acid 5 mg is the only proven therapy to reduce new clinical fracture and all-cause mortality (28% reduction in death) after a recent low trauma hip fracture7.
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Novartis announced recently that new six-year data reinforce the long-term efficacy and safety profile of once-yearly zoledronic acid 5 mg in postmenopausal women with osteoporosis1. The study of more than 1,200 women was presented at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

The study showed that zoledronic acid 5 mg preserved bone mass in postmenopausal osteoporotic patients who received annual infusions for six years1. In patients who stopped zoledronic acid 5 mg treatment after three years, the bone mineral density (BMD) decreased but remained well above the levels measured at the beginning of the study (difference between the two groups at six years: 1.04%, p=0.0009)1.

Patients who stayed on zoledronic acid 5 mg therapy for six years reduced their risk of new morphometric spine fractures by 52%, compared to those who stopped treatment at three years (p=0.04)1, the study also showed. Morphometric fractures can occur unaccompanied by pain and therefore may not be diagnosed and treated4. Over time patients can experience these fractures in the form of back pain, loss of height, or stooped posture4.

"These new findings show that continued treatment with zoledronic acid 5 mg for six years continues to maintain bone mass and reduces vertebral fractures risk with no change to its favorable safety profile compared to discontinuation of treatment after three years," said Dennis Black, PhD, the study's lead author and Professor of Epidemiology and Biostatistics at the University of California, San Francisco. "These new long-term data reconfirm zoledronic acid 5 mg as an important therapeutic option for doctors when considering an osteoporosis medicine for their patients."

In both study groups, the bone markers were maintained over six years within the normal premenopausal range1. In patients who discontinued zoledronic acid 5 mg after three years, there was no evidence of accelerated bone loss1. This builds upon existing data from extensive clinical studies and confirms that zoledronic acid 5 mg helps preserve bone turnover, the balanced process by which the bone is constantly renewed and remodeled throughout adult life.

"Zoledronic acid 5 mg is highly effective at protecting patients against osteoporotic fractures for a long period of time and its once-yearly dosing represents an important improvement for patients and doctors in terms of compliance for an entire year," said Trevor Mundel, MD, Global Head of Development at Novartis AG. "These long-term data affirm our confidence in the efficacy and safety profile of this medicine."

Osteoporosis is a condition in which bones become weak and break more easily4. According to the International Osteoporosis Foundation (IOF), an estimated 75 million people in Europe, USA, and Japan are affected by this disease5 and one in three women over the age of 50 as well as one in five men will suffer an osteoporotic fracture in their lifetime5.

This long-term study, which extended the HORIZON (Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly) Pivotal Fracture Trial by three years, is a multi-center, double-blind, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of zoledronic acid 5 mg in the treatment of postmenopausal osteoporosis1. The extension study evaluated more than 1,200 women aged 68 years or older1. After three years of therapy, participants were randomized to either receive an Aclasta infusion (n=616) or an annual placebo infusion (n=617) for additional three years1.

The primary endpoint of the study was the percentage change in the BMD at the femoral neck at year six vs. year three1. Secondary endpoints included evaluation of BMD at other sites, fractures, changes in bone turnover markers and overall safety1. The incidence of adverse events was comparable between groups1. There was no long-term effect on renal function or increase in risk of osteonecrosis of the jaw or atrial fibrillation1.

Zoledronic acid 5 mg provides year-long bisphosphonate compliance with a single infusion. Zoledronic acid 5 mg is the only yearly treatment approved in US and EU to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (e.g., wrist and rib)6. Additionally, it is also the only proven therapy to reduce new clinical fracture and all-cause mortality (28% reduction in death) after a recent low trauma hip fracture7.

Approved in more than 90 countries, zoledronic acid 5 mg is approved for up to six indications to treat a broad spectrum of patients, from the newly diagnosed to those with more severe forms of osteoporosis2. These include treatment of postmenopausal osteoporosis, prevention of postmenopausal osteoporosis, prevention of subsequent fractures after a low-trauma fracture, increase in bone mass in men with osteoporosis, treatment and prevention of glucocorticoid-induced osteoporosis in men and women, and treatment of Paget's disease of bone in men and women2.

Zoledronic acid 5 mg is generally well tolerated. Given as an infusion, it by-passes the gastrointestinal tract and avoids the potential side-effects like upper gastrointestinal irritation. The most common adverse events associated with zoledronic acid 5 mg are transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occur within the first three days following zoledronic acid 5 mg administration and usually resolve within three days. The incidence of such post-dose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly after zoledronic acid 5 mg infusion. These data are based on one of the most extensive osteoporosis clinical trial programs involving over 14,000 men and women.

About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

 

References:

  1. Black DM, et al. The Effect of 3 versus 6 Years of Zoledronic Acid Treatment in Osteoporosis: a Randomized Extension to the HORIZON-Pivotal Fracture Trial (PFT). American Society for Bone and Mineral Research (ASBMR) Annual Meeting. October 16, 2010.
  2. Novartis, IMS MIDAS Quarterly data, June 2010.
  3. Reclast (zoledronic acid) Injection Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. January 2010.
  4. National Osteoporosis Foundation. "Fast Facts on Osteoporosis" brochure. February 2008.
  5. International Osteoporosis Foundation fact sheet "Facts and Statistics about Osteoporosis and its Impact." September 10, 2010 at http://www.iofbonehealth.org/facts-and-statistics.html#factsheet-category-17.
  6. Black DM et al. Once Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. NEJM 2007: 356:1809 - 1822.
  7. Lyles KW et al. Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture. NEJM 2007; 357:1799 - 1809.