The following press release was issued by the FDA. While the seriousness and pain of bone fractures is significant, the side effect profiles of this drug sound pretty serious.   What is the risk/benefit ratio?   Is the trade-off worth it?  We would love to hear from women who are making these choices.

JUNE 1, 2010:   The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis.

People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and increase bone mass and strength. An injection of Prolia is recommended once every six months.

“Due to its prevalence, osteoporosis is a serious concern to public health,” said Julie Beitz, M.D., director of the FDA’s Office of Drug Evaluation III. “The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

The most common side effects reported with Prolia include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia causes significant suppression of bone turnover and this suppression may contribute to the occurrence of osteonecrosis of the jaw, a severe bone disease that affects the jaw, atypical fractures, and delayed fracture healing.

Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.

For more information about osteoporosis click here.

Comments

If Prolia has so many side effects I don't think I will let my grandma use it. I just wish there's a medicine that can help cure without any side effects.

In addition to Prolia, or any conventional treatment for that matter, I recommend a calcium-rich diet. Not only can it treat osteoporosis, but it can prevent it as well.

The transition to post menopause can be a long and somewhat frustrating journey, but there is help and support out there. Ladies are much more vocal about their experiences, and demand treatment that's safe, efficient and organic. Promensil's extensive testing has proven that organic supplements could be just that and without the side effects associated with hormone replacement therapy. Menopause treatment should be about making ladies feel like ladies, naturally.

Menopause or even perimenopause is really too late to begin thinking about bone health. Weight-bearing exercise beginning in adolescence throughout adulthood and healthy diets would, I believe, alleviate the problem. Natural, gentle health tactics pay off long-term.

Well I recommend bisphosphonates or hormonal replacement, both of which significantly help to correct abnormalities in bone metabolism, which is the central process in the propagation of bone changes in osteoporosis.

Dr. Gauresh.
St. George's Hospital.

Are you aware of any studies linking long term fluoride/toothpaste usage and the de-mineralization of bone (calcium depletion)? Thanks for a very interesting post.

I must say that this is a very original and inspiring take on education and one which we as teachers can all learn a lot from. I really enjoy reading your blog. Thankyou very much for this beautiful post. Thanks a lot.

Calcium at all ages! that ought to prevent osteoporosis.

I must state that your post is a graceful piece of information to me. While going through your blog I gained a good amount of informative facts that helped my knowledge in nourishing more.

"One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis."
With this kind of statistics, women have to take proper care of their health by getting tested frequently.

Very interesting article, having a mother who is post menopausal makes me think about the problems women have to face at that age. I think I wouldn't rely completely on any drug to treat osteoporosis but would approach it from many different ways. Combining a calcium rich diet, light resistance training to strengthen bones as well as appropriate drug therapies (but only as a last resort).

I am sure anyone suffering osteoporosis would be glad whenever a new drug is developed to help with their condition. I do hope it helps many of those already suffering. Like others commenting, I believe education and prevention with diet and lifestyle changes will help the many more future sufferers. The less pill we have to take the better I think.

A high calcium diet would be very helpful in the prevention of osteoporosis, however, if it is already in the latter stages of the disease. Then prolia is the answer currently, hopefully though a viable substitute would be formulated soon, on that has lesser or no side effects.

I'm glad we have a new option to combat osteoporosis, even if the new drug, like others, have harmful side effects. Really the best cure is prevention which must begin at home and in schools.

I feel bad for women. They have to go through so much during their lifetime. I mean i would hate to bleed every month and to have a child. God Bless all women!

Is there an update for injectable treatment for postmenopausal women with osteoporosis? Prolia causes significant suppression of bone turnover and I have friends that know a little bit about this matter. Maybe they can help answer some questions

THe problem with medications like Prolia is that they prevent the natural breakdown of bone. Osteolysis should occur daily and by preventing it you have the side effects of osteonecrosis as mentioned in the article. Although this may be an option for those women already diagnosed with osteoporosis, the better option for women is to have a healthy bone mass by eating a proper diet rich in calcium, magnesium and other minerals, getting plenty of sunlight for natural vitamin D production and daily resistance exercises.

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