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Welcome to the WebMD Osteoporosis Exchange with experts from the National Osteoporosis Foundation who rotate their time here.
FDA approves Prolia for High Risk Osteoporosis
A paragraph in another article about Osteoporosis Treatments : "Prolia is a so-called monoclonal antibody -- a fully human, lab-produced antibody that inactivates the body's bone-breakdown mechanism. It's the first "biologic therapy" to be approved for osteoporosis treatment . Prolia is approved for postmenopausal women with osteoporosis and high risk of fracture, and when other osteoporosis medicines have not worked."
The thing to remember is that your doctor feels the benefits outweigh the risks. Did you ask your doctor why they chose this drug?
Also, what meds you have tried in the past and tell us about your current condition.
In June 2010, Denosumab was approved by the FDA for the treatment of osteoporosis in postmenopausal women at high risk of fracture or breaking a bone. According to the package insert, being at high risk of fracture means that you meet one or more of the following conditions:
-you have already broken a bone from osteoporosis
-you have several risk factors for breaking a bone
-you have not been able to take other osteoporosis medicines due to side effects
-you have not received enough benefit from other osteoporosis medicines
Denosumab is a RANK ligand (RANKL) inhibitor/human monoclonal antibody. A healthcare professional gives denosumab by injection every six months. Patients need to have a blood test before each dose to confirm that blood calcium level is normal. As for all people with osteoporosis, it is very important to get enough calcium, vitamin D and exercise every day.
In clinical trials, denosumab significantly reduced the incidence of new spine fractures by 68 percent, reduced the incidence of hip fractures by 40 percent and reduced the incidence of all non-spine fractures by 20 percent over three years.
Side Effects
Denosumab may lower the calcium levels in the blood. If blood calcium levels are low before receiving denosumab, the low calcium level must be corrected before giving the medicine or it will get worse. Signs of low calcium levels include spasms, twitches or cramps in the muscles; or numbness and tingling in the fingers, toes or around the mouth. If any of these symptoms are seen while on this medicine, patients should contact their healthcare provider. Most patients with low calcium levels, however, do not show these signs.
People who have weak immune systems or take other medicines that affect the immune system may have an increased chance of having serious infections with denosumab. Even patients who have no immune system problems may be at higher risk of certain infections such as those of the skin. Patients should contact their healthcare provider right away if signs of infection occur. These signs may include fever, chills, red and swollen skin, skin that is hot or sore to the touch, severe pains in the abdomen, or pain or burning when passing urine or passing urine more frequently and in small amounts.
Denosumab may also cause skin rashes. Call your healthcare provider if you notice any abnormal skin-related symptoms. Denosumab has caused osteonecrosis of the jaw (ONJ) when used to treat patients with cancer although at this time, these have not been seen in patients with osteoporosis. Patients should practice good dental care during treatment and should have an examination of the mouth by a doctor or dentist before starting the medicine.
Other side effects can include back pain and musculoskeletal pain in the arms and legs.
I have have never had a fracture or any kind or balance problems ever, and I found out yesterday that Prolia costs over $1,000 per injection. There are 2 injections per year. With my insurance coverage I will have to pay $150 per injection. I did have my calcium level checked and am waiting for the results.
I was on Actionel and it was ineffective. I am 63 and am 5'9" and weight 130 lbs. While on Forteo it was recommended that I not weigh less than 127. I am in excellent health, I workout with weights and also take various aerobic classes at the Y in town. On the weekends we walk 10 miles. So I feel that I am the poster-child for good health.
Let me know what you think about this situation. I am going to wait until January 2011 before I make any decisions.
The fact that you haven't broken a bone is wonderful. You also exercise (although I'd be wary of the aerobic if your bone density is low) and take your calcium and Vit D. All excellent.
Forteo builds new bone and it sounds like it did the job for you. Since the Actonel was ineffective you need something to strengthen that new bone. That's where the Prolia comes in.
It is expensive, but is covered under your medical, not drug, insurance since it's given in a health care setting by a health care professional. If your portion is $150 a shot, I'd say that was pretty reasonable. I can tell you that the cost of having a hip or spinal fracture is much more than that and the life altering effects last a lifetime.

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