Study Shows Single Dose of Reclast Prevents Postmenopausal Osteoporosis for at Least 2 Years
New study shows single-dose of Reclast® prevents osteoporosis for at least two years in postmenopausal women with low bone mass
--Approximately 34 million individuals in US have osteopenia, or low bone mass, putting them at risk for osteoporosis(1)
--Postmenopausal women with low bone mass are at increased risk of experiencing a bone fracture compared to those with normal bone mass(2)
--This new data reinforces the safety and efficacy of Reclast, used in more than 425,000 patients worldwide to date(3)
East Hanover, NJ, April 3, 2009 – Novartis Pharmaceuticals Corporation today announced the results of a new study finding that one infusion of Reclast® (zoledronic acid) Injection prevents osteoporosis for at least two years in postmenopausal women with osteopenia(4). The study, presented at the 8th Annual National Osteoporosis Foundation-sponsored International Symposium on Osteoporosis, found that Reclast significantly increased bone mineral density (BMD) in osteopenic women after two years compared to placebo (p<0.0001)(4).
Nearly 34 million men and women in the U.S. have osteopenia, or low bone mass, putting them at increased risk for osteoporosis(1). In fact, postmenopausal women with osteopenia are more likely to experience a bone fracture compared to those with normal bone mass(2), highlighting the importance of treating and preventing further bone loss in these women.
“This is the first study to evaluate whether an osteoporosis medication given once every two years can prevent bone loss in women with osteopenia,” said Mone Zaidi, MD, PhD, Professor of Medicine, Geriatrics, and Physiology and Director of The Mount Sinai Bone Program at Mount Sinai School of Medicine. “It is exciting that these women may have a treatment option that only needs to be taken once every two years, rather than on a weekly or monthly basis.”
Reclast is currently FDA approved as a once-yearly treatment for postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, and for the treatment and prevention of glucocorticoid-induced osteoporosis(5). Reclast is also approved for the treatment of Paget’s disease of bone in men and women(5).
Since its launch in 2007, Reclast has been used by more than 425,000 patients worldwide, including more than 220,000 in the US, to help prevent fractures(3). It is available in all 50 US states and reimbursed by all Medicare Part B carriers and virtually all health insurance plans(6). Reclast can be administered in physician offices or in one of the more than 5,500 infusion centers located throughout the US(7).
About the Reclast Osteoporosis Prevention Study
This randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and safety of Reclast at preventing bone loss in postmenopausal women with osteopenia(4). The women included in the study were 45 years and older with low BMD levels, defined as having a T-score between -1.0 and -2.5 at the lumbar spine and greater than -2.5 at the femoral neck(4).
A total of 531 postmenopausal women were randomized to receive one of three regimens: Reclast at the start of the study and again at one year (Regimen A), Reclast at the start of the study and placebo at one year (Regimen B), or placebo at both the start of the study and at one year(4).
The study’s primary endpoint was percentage change in lumbar spine BMD at two years compared to the start of the study. Secondary endpoints included changes in lumbar spine, total hip, femoral neck, trochanter, and distal radius BMD after one and two years as well as changes in bone turnover markers(4).
At two years, both Reclast treatment regimens significantly increased BMD at the lumbar spine, compared to placebo (Regimen A: 5.31% and Regimen B: 4.55% versus Placebo: -1.19%; both P<0.0001) (4).
The overall incidence of adverse events was similar in the three treatment regimens except during the first three days post-infusion(4). This difference was mainly driven by transient post-dose symptoms (such as fever; pain in the muscles, bones or joints; flu-like symptoms; and headache) in the Reclast treatment groups, which are generally seen within the first three days after the infusion(4).
Furthermore, both Reclast regimens were superior to placebo at increasing BMD at the lumbar spine at one year and BMD at total hip, femoral neck, and trochanter at one and two years(4). Both Reclast regimens also reduced bone turnover markers significantly more than the placebo regimen at both one and two years(4). However, during the second year, bone turnover marker reductions were greater in the Reclast group given Reclast again after one year than in the Reclast group given placebo after one year(4).
The active ingredient in Reclast is zoledronic acid 5 mg administered once a year when treating postmenopausal osteoporosis(5). Reclast contains the same active ingredient found in Zometa® (zoledronic acid) Injection.
You should not take Reclast if you’re on Zometa® (zoledronic acid) Injection because it contains the same active ingredient. Additionally, you should not take Reclast if you have low blood calcium, kidney problems, or are allergic to Reclast. If you are pregnant, plan to become pregnant, or are nursing, you should not take Reclast.
It’s important to drink fluids before getting Reclast to help prevent kidney problems. The most common side effects include flu-like symptoms, fever, muscle or joint pain, headache, nausea, vomiting and diarrhea. Tell your doctor if you have dental problems because rarely, problems with the jaw have been reported with Reclast. Discuss all medicines you are taking, including prescription and non-prescription drugs, vitamins, and herbal supplements. If you develop severe bone, joint, or muscle pain, numbness, tingling or muscle spasms, contact your doctor.
The foregoing release contains forward-looking statements that can be identified by terminology such as “risk,” “more likely,” “can,” “may,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Reclast or regarding potential future revenues from Reclast. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Reclast to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Reclast will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that Reclast will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Reclast could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, GI and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which 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, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals, and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group’s continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,700 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
1. National Osteoporosis Foundation. Fast Facts on Osteoporosis Brochure. February 2008.
2. Siris ES, et al. Bone Mineral Density Thresholds for Pharmacological Intervention to Prevent Fractures. Arch Intern Med. 2004; 164:1108-1112.
3. Novartis Internal (NPMR), based on Aclasta/Reclast vials sold in the US since launch till Feb 2009.
4. McClung MR, et al. Efficacy and safety of zoledronic acid in the prevention of osteoporosis in postmenopausal women with osteopenia: the HORIZON Prevention Study. April 3, 2009.
5. Reclast® (zoledronic acid) Injection [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2009.
6. Novartis Health Policy; USMM; Lash Group.
7. Reclast Ready Report; 2009, Novartis Data on File. Novartis Pharmaceutical Corporation.
Posted: April 2009