Make your own free website on Tripod.com

Young People Get Osteoporosis Too 

Butterfly1b1  RECLASTButterfly1b5

Home • Up • SITE MAP • MY STORY • FAQ'S • DEXA SCANS • DIAGNOSIS • TREATMENT • DIET • EXERCISE • CALCIUM • VITAMIN D • DRUGS IN DEVELOPMENT • RESEARCH • NEWLY DIAGNOSED • ALTERNATIVES • FRACTURES • KYPHOPLASTY • VERTEBROPLASTY • RELATED DISORDERS • MISC INFO • ASK A DOCTOR • MYTHS • OSTEOPOROSIS FACTS • GLOSSARY • ARTICLES • LINKS • ADVOCACY • SUPPORT GROUP • AWARDS


Free E Cards • Email

 

DISCLAIMER:

Please be advised that the inclusion of any medication on this site is not indicative of an endorsement.  I do not have any affiliation with the pharmaceutical corporations that manufacture prescription osteoporosis medications.  I am not a doctor, therefore I am not medically qualified to counsel or advise osteoporosis patients about which medication is best suited for their individual case.

• actonel • aredia • boniva • didronel • evista • Forteo • fosamax • miacalcin • zometa • vivelle • reclast •


Reclast is a medicine used to treat:
• Osteoporosis in women after menopause
• Men and women with Paget’s disease of the bone

Reclast strengthens your bones by increasing bone mass and lowers the chance of breaking bones (fractures). IMPORTANT: You should not receive Reclast if you are already receiving Zometa. Reclast and Zometa are the same medicine. They both contain zoledronic acid.

Facts about Reclast:

  • receives US FDA approval as first and only once-yearly treatment for women with postmenopausal osteoporosis
     
  • Shown to be highly effective in strengthening bones and protecting against osteoporosis-related fractures, including spine and hip
     
  • Reclast reduced spine fractures by 70% and hip fractures by 41% compared to placebo in study published in New England Journal of Medicine
     
  • Unique once-yearly dosing provides potential for significant compliance benefits
     
  • Osteoporotic fractures affect one in two women over 501 and are associated with increased morbidity, mortality and healthcare costs

What are the possible side effects of Reclast?

  •  Low blood calcium (hypocalcemia).
     
  •  Kidney problems. Your doctor may do a blood test to check your kidney function before each dose of Reclast. It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Reclast, as directed by your doctor.
     
  • Jaw-bone problems (Osteonecrosis of the jaw). Jaw-bone problems may occur in some people and include: infection, delayed healing after teeth are pulled.
     
  • Severe muscle, bone and joint pain. Tell your doctor if you have severe muscle, bone, or joint pain after receiving Reclast.
     
  • The most common side effects of Reclast include: flu-like illness, fever, pain in your muscles or joints, and headache that can happen in the days after you get Reclast. A mild pain reliever such as ibuprofen or acetaminophen may reduce these symptoms. The chance of getting these side effects goes down with repeat dosing of Reclast.
    Tell your doctor about any side effect that bothers you or does not go away.
      

What is the most important information I should know about Reclast?

  • Low blood calcium should be corrected prior to receiving Reclast.
  • You should take calcium and vitamin D daily as recommended by your health care professional.
  • Patients with severe kidney problems should not receive Reclast Injection.

Reclast may not be right for you.  Tell your doctor about all your medical conditions, including if you:

  • have kidney problems
  • have a history of low blood calcium
  • are not able to take daily calcium and vitamin D supplements
  • had parathyroid or thyroid surgery (these glands are located in your neck)
  • have a malabsorption syndrome
  • had sections of your intestine removed
  • have asthma (wheezing) from taking aspirin
  • have a planned dental surgery such as tooth extraction
  • are pregnant or plan to become pregnant, Reclast may harm your unborn baby
  • are breast feeding or planning to breast feed.  It is not known if Reclast passes into breast milk

Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, herbal supplements, and vitamins.
Some medicines may increase your chance for low blood calcium levels or kidney problems when used with Reclast.
Especially tell your doctor if you are taking:

  • Zometa
  • a diuretic or water pill
  • an antibiotic--certain antibiotics called aminoglycosides may increase the effect of Reclast in lowering your blood calcium for a long period of time.
    Know the medicines you take.  Keep a list of your medicines and show it to your doctor and pharmacist each time you get a new medication

How will I receive Reclast?

  • Reclast is given by infusion into a vein (IV) that takes at least 15 minutes time.  Reclast is always infused by your doctor or nurse
  • Drink at least 2 glasses of fluid such as water, within a few hours before receiving Reclast as directed by your doctor,  You may eat normally before your infusion.
     

For Osteoporosis:

  • Reclast is given once a year, if you are wandering how does it continue to work for a year or longer. .think about it as a coating for your bones, basically this compound probably has a longer residence time on bone, so when osteoclasts come try to chew up or resorb bone, the agent is still there and still effective
     
  • In women with osteoporosis, the current recommended daily intake of calcium is 1200 mg and vitamin D 400 IU to 800 IU daily.  If you have osteoporosis you should take calcium and vitamin D daily as recommended by your doctor. 
     
  • During treatment with Reclast, your doctor may order a bone mineral density test to check your osteoporosis


     


East Hanover, NJ, August 17, 2007 – Reclast® (zoledronic acid) Injection has been approved by the US Food and Drug Administration as the first and only once-yearly
medicine for postmenopausal osteoporosis, offering an important new approach to the treatment of a bone disease affecting eight million women in the US1.
Unlike oral bisphosphonate therapies that have to be taken daily, weekly or monthly, Reclast is given as a once-yearly 15-minute intravenous (IV) infusion. This means with a single treatment a patient can receive a full year’s protection against the effects of osteoporosis – a disorder that causes bones to break easily. “The fact that Reclast is highly effective and can be administered once-yearly represents a major milestone in the treatment of postmenopausal osteoporosis,” said Felicia Cosman, MD, Professor of Clinical Medicine, Columbia University. “For the first time we can ensure women receive a full year of the treatment they need to protect their bones,” said Dr. Cosman.
The US approval comes a few weeks after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for the medicine in the European Union, under the brand name Aclasta®. The European Commission generally follows the CHMP’s recommendations and is expected to issue a final decision within three months.

The regulatory submissions were based on efficacy and safety data from a three-year
Pivotal Fracture Trial, showing that Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and nonspine (i.e. hip, wrist, arm, leg, rib). Reclast is the only treatment proven to reduce fractures across all of these key sites.2/4 In this study involving more than 7,700 women, Reclast reduced the risk of spine fractures by 70% and hip fractures by 41% (The New England Journal of Medicine, May 3, 2007) 2. The reduction in spine fractures was sustained over three years (60% in year one, 71% in year two, and 70% in year three). Bone mineral density increased significantly in the spine by 6.7% and the hip by 6% in women on Reclast compared to placebo2.“Reclast has shown significant efficacy in protecting women against fractures in all the common osteoporotic fracture sites, while demonstrating a favorable safety profile,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG. “It is our hope that this innovative once-yearly dosing regimen will have a positive impact on the management of this potentially devastating condition.”
The need for effective treatments is pressing, with one out of every two women over the age of 50 suffering an osteoporotic fracture in her lifetime1. The disease is responsible for 1.5 million fractures in the US every year1, some of which can have severe consequences. Approximately 20% of women over the age of 50 who suffer a hip fracture will die within one year1.

Osteoporotic fractures are responsible for an estimated 800,000 emergency room visits, 500,000 hospitalizations, 180,000 nursing home placements, and 2.6 million physician visits in the US each year3, costing the healthcare system approximately $12.2 to 17.9 billion annually3. “Osteoporosis is a serious disease affecting millions of people in this country,” said Leo Schargorodski, executive director of the National Osteoporosis Foundation (NOF). “NOF welcomes new FDA approved treatment options, such as Reclast, that give patients a choice when it comes to taking their osteoporosis therapy.” Reclast/Aclasta is approved in more than 60 countries, including the US, Canada and the EU for the treatment of Paget’s disease, the second most common metabolic bone disorder.

Additional studies are ongoing to examine the use of Reclast to prevent fractures following a hip fracture in men and women, treatment of corticosteroid-induced osteoporosis, and male osteoporosis. The active ingredient in Reclast is zoledronic acid, which is also available in a different dosage under the brand name Zometa® (zoledronic acid 4 mg) Injection for use in certain oncology indications.

Reclast is contraindicated in patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Reclast contains the same active ingredient found in
Zometa. Patients already being treated with Zometa should not be treated with Reclast. Reclast should not be used during pregnancy because of potential harm to the fetus. Reclast is not recommended for use in patients with severe renal impairment (creatinine clearance <35 mL/min) and infusion time should not be less than 15 minutes. The most common side effects associated with Reclast are fever; pain in the muscles, bones or joints; flu-like symptoms; and headache. These symptoms usually occur within the first three days following Reclast administration and usually resolve within 3 to 4 days of onset but resolution could take up to 7 to 14 days. Patients have reported severe bone, joint and/or muscle pain after using bisphosphonates. Osteonecrosis of the jaw (ONJ) has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A routine oral examination should be performed by the prescriber prior to initiation of ¾ bisphosphonate treatment. Hypocalcemia may occur with Reclast therapy. In the Pivotal Fracture Trial an increased number of cases of serious atrial fibrillation were observed in women given Reclast compared to those on placebo (1.3% vs. 0.4% respectively)2. The timing of these events suggest that they were not related to the acute infusion. This finding has not been observed in other zoledronic acid clinical studies and in post-marketing experience from more than 1.5 million patients treated with Zometa. All patients with Paget’s disease should receive 1500 mg of calcium in divided doses and 800 IU of vitamin D daily, particularly in the two weeks following Reclast administration.It is recommended that patients with postmenopausal osteoporosis take calcium and vitamin D supplements, if dietary intake is not sufficient.


For more information about Reclast, visit www.reclast.com or call 866-RECLAST (866-732-5278).


References
1 National Osteoporosis Foundation. About Osteoporosis: Fast Facts. Available at:
http://www.nof.org/osteoporosis/diseasefacts.htm Accessed on June 7, 2007.
2 Black D, Delmas, S, Eastell R et al for the HORIZON Pivotal Fracture Trial. Once-Yearly Zoledronic Acid
for Treatment of Postmenopausal Osteoporosis. NEJM 2007; 356(18):1809-22.
3 U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon
General. 2004.