Update on Medicines for Osteoporosis - New Guidelines for “Bisphosphonate Holidays”

Bisphosphonates like Fosamax®, Boniva®, and Actonel® have been used for the past twenty-five years for osteoporosis but new research continues to add more information.

A “bisphosphonate holiday” stops the medication for a period of time after someone has been taking bisphosphonates for three to five years. According to new guidelines from the American Society of Bone and Mineral Research, this “bisphosphonate holiday” is still a good idea for women who have been taking bisphosphonates, but are at lower risk for fracture.

However, the guidelines now recommend that women with osteoporosis who remain at high risk can benefit from non-stop treatment for up to ten years with oral bisphosphonates, or up to six years with intravenous bisphosphonates. High risk women include those being treated who are older, or have a low hip T-score, or have had a fragility fracture while being treated. When treatment is continued there is no increased risk of jaw necrosis but the risk of atypical femoral fracture does increase. Here is a link to more information about management of low bone density.

While it’s best to avoid medications when possible, bisphosphonates have helped millions of women and men decrease their risk of broken bones. One big problem is that most women don’t continue their treatment because they can’t tolerate the oral medicines or because of difficulty arranging intravenous treatment. A piece of good news is that a new drug called Romosozumab has just started Phase 3 Clinical Trials and may be available for general use in the next few years. This drug is different from bisphosphonates because it targets a specific protein in bone. This can help form new bone instead of just stopping bone loss like bisphosphonates. Also, it’s very specific so the side effects should be much less than other bone drugs.

New drugs have to go through testing in laboratory and non-human subjects before it can be used for human clinical trials. Each phase takes several years to complete. During Phase 1 clinical trials, the researchers test the drug on a small group of human volunteers to evaluate safety and determine a dosage range. During Phase 2 more people use the medication to further evaluate safety and effectiveness. During Phase 3 a very large group of people use the drug under strictly controlled conditions with careful observation of side effects and results.

After successful completion of Phase III, the drugs may become available to the public by prescription, but the drug companies continue to monitor for effectiveness and safety. Even after getting to Phase 3, only half of all drugs make it to final approval by the FDA for general use. This long process is important for safety, but it also explains why new drugs require ten to eighteen years from laboratory to general use and the cost may exceed a billion dollars even when successful. In spite of these obstacles, Romosozumab was first discovered in 2002 and may be a major advancement in the treatment of osteoporosis.

Even if you are taking medications for bone health, the results are better when they are combined with appropriate supplements of vitamins and minerals. Also supplements may help improve bone health for those at risk when combined with a healthy lifestyle and regular exercise. It’s never too early to begin a good supplement for your bone health and Silical® System is a breakthrough product that provides silicon in addition to eight other nutrients that are often deficient in the typical North American diet.

** Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.

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