Yearly Osteoporosis Drug Shows Great Promise

It’s a drug that could change the lives of women with postmenopausal osteoporosis and it only has to be taken once a year.

Clinical trials on a drug called Aclasta made by Swiss company Novartis showed the medication greatly reduced the risk of fractures in women with the metabolic disease.

The findings of phase III trials of the drug, which will be called Reclast, were presented in Philadelphia last week and the yearly treatment showed benefits across the most common fracture sites, including the hips, spine, wrist, and upper arm.

“It felt like a hand grenade went off in my back, the pain was so excruciating,” said osteoporosis patient Gail Lemieux, who’s suffered several fractures.

“For people with low bone density, like what I have, that’s an enormous bonus.”

Approximately 7,700 women with postmenopausal osteoporosis (PMO) in 27 countries participated in the trials that lasted three years. Some women were given the yearly injection of Reclast and others received a placebo.

Novartis says participants who received the drug experienced a 70 percent risk reduction in new spine fractures and a 40 percent risk reduction in hip fractures.

The side effects of the drug are said to be relatively minor and included fever, muscle pain, flu-like symptoms and bone pain. Most of these symptoms occurred within three days of the injection and cleared up within three days.

Reclast, also known as zoledronic acid, has been approved for use in about 50 countries to treat Paget’s disease and is currently awaiting approval from the U.S. Food and Drug Administration.

What is it?

Osteoporosis is disease that causes bones to become fragile and therefore very easy to fracture with the hips, the spine and wrist being the areas most at risk. The disease is characterized by low bone mass and the deterioration of bone tissue.

According to Osteoporosis Canada, one in four women over the age of 50 will get the disease and one in eight men.

What are the risk factors?

Certain people are more likely to develop the disease than others. Here’s what you should look out for:

Major Risk Factors

• being 65 or older
• having a family history of osteoporotic fracture (especially if your mother had a hip fracture)
• having a vertebral compression fracture, or a fracture with minimal trauma after age 40
• long-term (more than 3 months) use of glucocorticoid therapy such as prednisone
• medical conditions (such as celiac or Crohn’s disease) that inhibit absorption of nutrients
• primary hyperparathyroidism
• tendency to fall
• osteopenia apparent on x-ray
• hypogonadism
• early menopause (before age 45)

Minor Risk Factors

• rheumatoid arthritis
• hyperthyroidism
• prolonged use of anticonvulsants
• body weight less than 57 kg (125 lbs)
• present weight more than 10 percent below weight at age 25
• low calcium intake
• excess caffeine (consistently more than 4 cups a day of coffee, tea or cola)
• excess alcohol (consistently more than 2 drinks a day)
• smoking

Estrogen levels play a big role in bone tissue and in the first five to ten years after menopause, rapid bone loss begins. All post-menopausal women and men are advised to talk to their doctors about being assessed for the symptoms of osteoporosis.

Prevention:

Prevention starts young, as a woman has built up 98 percent of her skeletal mass by the age of 20. There are steps you can take in adulthood to prevent this disease, which include:

• A balanced diet rich in calcium and vitamin D
• Weight-bearing and resistance-training exercises
• A healthy lifestyle with no smoking or excessive alcohol intake
• Talking to one’s healthcare professional about bone health
• Bone density testing and medication when appropriate

Information provided by the National Osteoporosis Foundation in the United States.

How much calcium/vitamin D do I need?

Calcium is important for building strong bones in childhood and maintaining good bone density throughout adulthood. It’s also important to get the right amount of Vitamin D, because it aids in the absorption of calcium. Here’s a look at how much you should be getting everyday:

How do I choose the right supplement?

Supplements are meant for people who aren’t getting enough calcium in their diet and there are a number of products on the market, the most popular being calcium carbonate.

Osteoporosis Canada advises looking for a product that states the amount of elemental calcium per tablet, ie. 1000mg of calcium carbonate contains 400mg of calcium.

Also, look for products that have a Drug Identification Number (D.I.N.) or a General Product (G.P.) number – that lets you know that it meets Canadian standards. The American equivalent is the United States Pharmacopoeia (U.S.P.) number.

To maximize the absorption of calcium, Osteoporosis Canada recommends doing the following:

• Take calcium carbonate with food or immediately after eating
• Take calcium with plenty of water
• Take no more than 500 mg of elemental calcium at one time

What are some good dietary sources of calcium?

Dairy products such as milk, cheese and yogurt are great sources of easily absorbed calcium. Vegetables are also a great source, as are fish products containing bones (canned sardines and salmon) and meat alternatives like lentils and beans.

Osteoporosis Canada also advises you to pay attention to foods you’re eating that may cause calcium loss including caffeinated products and salty foods. 

Information courtesy the Public Health Agency of Canada and Osteoporosis Canada, except for prevention – information provided by the National Osteoporosis Foundation.

For more information on osteoporosis, including more information on how to get more calcium in your diet, visit the Public Health Agency of Canada.

For other important resources, including a calcium calculator, which will help you determine whether you’re getting enough for your age, visit the Osteoporosis Society of Canada.

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