Adherencia a la medicación y al tratamiento

Medicines Approved to Prevent and/or Treat Osteoporosis

Types of Osteoporosis Medications

Available therapies for osteoporosis are effective in preventing osteoporosis and can reduce fracture risk by more than 50%.

There are two categories of osteoporosis medications: antiresorptive medications that slow bone loss and anabolic drugs that increase the rate of bone formation.

Bone Remodeling Cycle

Bone is living, growing tissue that constantly forms new bone while replacing older bone. Bone continuously renews and changes through a process called remodeling. The bone remodeling cycle consists of two distinct stages: (1) bone resorption (breakdown or removal) and (2) bone formation. During resorption, special cells (osteoclasts) on the bone’s surface dissolve bone tissue and create small cavities. During formation, other cells (osteoblasts) fill the cavities with new bone tissue.

Usually, bone resorption and bone formation take place in close sequence and remain balanced. An imbalance in the bone remodeling cycle occurs with menopause and with aging in both genders, and it can occur with other conditions. An imbalance can result in bone loss that eventually leads to osteoporosis and broken bones (also called fractures).

Antiresorptive Medications

Bisphosphonates, calcitonin, denosumab, estrogen and estrogen agonists/antagonists are antiresorptive medicines. They slow the bone loss that occurs in the breakdown part of the remodeling cycle. When people first start taking these medicines, they stop losing bone as quickly as before, but still make new bone at the same pace. Therefore, bone density may increase. The goal of treatment with antiresorptive medicines is to prevent bone loss and lower the risk of breaking bones.

Anabolic Drugs

Teriparatide, a form of parathyroid hormone, increases the rate of bone formation and is in a distinct category of osteoporosis medicines called anabolic drugs. This is currently the only osteoporosis medicine approved by the FDA that rebuilds bone. The goal of treatment with teriparatide is to build bone and lower the risk of breaking bones.

Special Note

Information provided here about the FDA approved osteoporosis medicines is intended solely for general information and should NOT be relied upon for any particular diagnosis, treatment or care. This information does not imply an endorsement by BHOF of any particular medicine or manufacturer.

For more detailed information on the actions, administration and possible side effects for each of the following medicines, please consult the package insert, available online and at pharmacies.

Osteoporosis Medications

• Alendronate Sodium or Alendronate Sodium plus Vitamin D3 (Fosamax® and Fosamax Plus D)
• Ibandronate Sodium (Boniva®)
• Risedronate Sodium or Risedronate Sodium with Calcium Carbonate(Actonel®, Actonel® with Calcium and Atelvia^TM)
• Zoledronic Acid (Reclast®)
• Side Effects of Bisphosphonates (Alendronate, Ibandronate, Risedronate and Zoledronic Acid)
• Calcitonin-Salmon (Fortical® and Miacalcin®)
• Denosumab (Prolia®)
• Raloxifene (Evista®)
• Teriparatide Parathyroid Hormone (PTH) (1-34) (Forteo®)
• Menopausal Hormone Therapy (MHT) (Multiple brands available)
• Tissue-Selective Estrogen Complex: Conjugated Estrogens/Bazedoxifene (Duavee®)
• Bioidentical Hormones

Response to Treatment

A medicine that is appropriate and effective for one person may not be the best choice for another person. People can respond differently to treatment with the same medicine.

To be effective, an osteoporosis medicine must be taken as prescribed. It is important to stay with the plan on which you and your healthcare provider have agreed. Most people cannot feel their bones getting stronger (or weaker) in response to treatment with a medicine. So if you decide that a particular treatment plan is not right for you, discuss your concerns with your healthcare provider before stopping or interrupting treatment. For your medicine to work, you need to exercise regularly and continue to get enough calcium and vitamin D.

With the antiresorptive medicines (bisphosphonates, calcitonin, estrogen, estrogen agonists/antagonists and denosumab), the goal of treatment is to prevent further bone loss and to reduce the risk of fractures. Fractures can cause deformities, disabilities, and serious, as well as life threatening complications. A patient has a favorable response to treatment when bone mineral density either remains stable or improves and no broken bones occur.

With the one anabolic medicine, teriparatide (Forteo®), the goal of treatment is to rebuild bone, increase bone mass, repair microscopic defects in bone and reduce the risk of fractures. A patient has a favorable response to treatment when both bone quantity and quality improve and there is a substantial increase in bone strength.

Monitoring Treatment

Most healthcare providers repeat the bone density test at least every two years to monitor the effectiveness of treatment with an osteoporosis medicine. Healthcare providers may have some patients repeat a bone density test in one year. Bone density tests and blood and urine tests called bone markers are the most available monitoring tools. At the current time, there is no easy way to measure improvement in bone quality.

Past Experience and Studies

Past experience with bisphosphonates (Actonel®, Boniva® and Fosamax®) suggests that upon discontinuation of any of these drugs, the benefits may continue for several years or longer. This is because the drugs remain in the bone for a long time. Eventually, however, the beneficial effect begins to lessen, bone remodeling rates increase and bone loss may occur.

One study found that alendronate (Fosamax®) continued to have a beneficial effect on bone mineral density for up to 10 years in postmenopausal women taking the medicine. Biopsies of bone tissue in women on alendronate for 10 years show that bone tissue looks healthy and normal. Other studies show that treating with alendronate for more than five years improves bone strength and reduces fractures of the spine.

Another study suggested that women who discontinued taking alendronate after five years of treatment did not significantly increase their fracture risk for up to an additional five years. Women who stopped alendronate after five years had the same rate of non-spine fractures as women who continued using the drug for 10 years. However, the study found that women at very high risk of spine fractures may benefit by continuing to take alendronate beyond five years.

How Long to Treat

There are currently no conclusive research findings to suggest how long an osteoporosis drug remains safe and effective, except for teriparatide (Forteo®). Teriparatide can be taken for no more than two years according to the FDA. It is uncertain how long any of the osteoporosis medicines remain effective after they are stopped.

In the absence of clinical studies on duration of treatment, healthcare providers and patients should discuss options to determine the best course of action. BHOF encourages all healthcare providers to evaluate a patient on the basis of clinical risk factors, such as the presence or absence of fractures, bone density status, age, weight, smoking and alcohol use. Length of treatment should be individualized and based on the person’s medical and fracture history, as well as the initial and most recent bone mineral density test results.

It is good practice to reevaluate the need to continue your medicines every year with your healthcare provider. After three to five years of taking a bisphosphonate medicine, individuals should discuss whether they should continue taking the medicine, stop taking the medicine or consider switching to a different medicine. Always talk to your healthcare provider first, before making any changes to your treatment plan.

When a patient has a good response to treatment with an osteoporosis medicine, some healthcare providers will consider a drug holiday. This means stopping the medicine for a period of time and continuing to monitor bone mineral density. Some healthcare providers consider a drug holiday after five years when there has been a good response to treatment. Others view it as an option when bone mineral density tests are performed two years apart, and the test results are similar and show a good response to treatment.

Although some healthcare providers give drug holidays, there are few research findings that support (or not support) this practice.

Serious Side Effects

Each individual should talk with their healthcare provider about the risks and benefits of taking or not taking a prescription medicine. While most individuals do not experience any serious side effects, if you have a serious reaction or problem with a drug, either you or your healthcare provider should notify the FDA to report the problem. The toll free number for the FDA is 1 (800) 332-1088. To complete a report online, visit the FDA Web site at www.fda.gov/medwatch. You may want to notify the pharmaceutical manufacturer of the adverse event. Find the phone numbers of the pharmaceutical manufacturers and the date each medicine was approved by the FDA as an osteoporosis medicine here.

Maximizing Your Treatment

Many people have trouble taking their medicines. People with osteoporosis often take one or more medicines for other conditions as well. They may worry about the risks and side effects or find the instructions for taking a medicine confusing or complicated. When you have questions about your medicines, be sure to speak with your healthcare provider or pharmacist.

When you take an osteoporosis medicine, you will not feel your bones getting stronger. This can make it hard to stay on a treatment plan. But it’s important that you take your medicine if you want it to work. You should take it just as your healthcare provider prescribed it, and you must remember to continue to take it. You also need to exercise regularly and get enough calcium and vitamin D.

If you decide that a treatment is not right for you, don’t just stop taking the medicine. First, talk with your healthcare provider about your concerns. When prescriptions are not filled, or if they are forgotten, taken incorrectly or stopped early, your health may not improve or could get worse. Studies show that if you take your osteoporosis medicine half of the time or less, it is the same as if you don’t take it at all.  Healthcare providers may find it difficult to figure out why you are not getting better. They might think the medicine did not work or that another health condition may be present. This can lead to extra tests, prescriptions, costs and broken bones that may have been prevented by taking the medicine as directed.

With antiresorptive medicines, the goal of treatment is to prevent more bone loss and to reduce the risk of breaking bones in the future. Your response to treatment is considered good if your bone density either stays the same or improves and if you don’t break any bones.

With anabolic medicine, the goal of treatment is to build new bone, increase bone density, repair tiny defects in bone and reduce the risk of broken bones. Your response to treatment is considered good if the rate of bone formation increases and your bone density improves and if you don’t break any bones.

To find out how your treatment is working, your healthcare provider will repeat your bone density test every two years. In some cases, healthcare providers will also use special lab tests called bone marker tests or biochemical marker tests to see if patients are losing bone faster than normal. While there is no easy way to measure improvement in bone quality, research in this area is currently underway.

You should be sure to see your healthcare provider regularly and review your medicines at each visit.  This will help to find any side effects of the medicine and make sure you are responding to it as you should.

Taking Medicines Safely

Medicines are used to treat any number of conditions and are generally safe when used as prescribed or as their labeling describes. There are, however, risks in taking any medicine. Each year in the United States, adverse drug events—injury resulting from the use of medication—result in over 700,000 visits to hospital emergency departments. Many adverse drug events are preventable. You can help reduce the risk of harm from medicines by learning about medication safety.

The following information is provided by the National Institutes of Health

Older Adults and Medications

Older people as a group tend to have more long-term, chronic illnesses such as arthritis, diabetes, high blood pressure and heart disease than any other age group. Because they may have a number of health problems or issues at the same time, it is common for older people to take many different drugs. Here are some tips on how to take medicines safely and get the best results from them.

Take Your Medicines Safely

Watch the 5 min 11 sec video

Understanding Your Medication

If your doctor prescribes a medication for your condition, try to find out as much about it as you can, including how to take it properly. Ask the following questions and write down the answers before leaving the doctor’s office.

• What is the name of the condition this medicine will treat?
• What is the name of the medicine?
• How does it treat my condition?
• What is the name of its active ingredient?
• Did you check that it doesn’t contain anything I’m allergic to?
• How long will it take to work? How should I store the medication? Does it need to be refrigerated?
• Can the pharmacist substitute a less expensive, generic form of the medicine?

Find Out How to Take the Medication

Ask your doctor, pharmacist, or nurse about the right way to take any medicine before you start to use it. Ask questions when you don’t know the meaning of a word, or when instructions aren’t clear. Here are some specific questions to ask.

• Should I take it as needed or on a schedule?
• Should I take it at a certain time of day?
• How much should I take each time?
• Do I need to take it with food?
• May I drink alcohol while on this medication?
• How long will I have to take it?

Ask What to Expect

• How will I feel once I start taking this medicine?
• How will I know if this medicine is working?
• If I forget to take it, what should I do?
• What side effects might I expect? Should I report them?
• Can this medicine interact with other prescription and over-the-counter medicines — including herbal and dietary supplements — that I am taking now?

Tips for Taking Medicines Properly

Taking different medicines is not always easy to do properly. It may be hard to remember what each medicine is for, and how and when you should take each one. Here are some helpful hints about taking medicines.

• Check the label on your medicine before taking it to make sure that it is for the correct person — you.
• Read and save any written information that comes with the medicine.
• Take the medicine according to the schedule on the label.
• Don’t take more or less than the prescribed amount of any medicine.
• If swallowing tablets is difficult, ask your doctor or pharmacist whether there is a liquid form of the medicine or whether you could crush your tablets. However, do NOT break, crush, or chew tablets without asking a health professional first.
• Get into the habit of checking the expiration dates on your medicine bottles, and throw away medicine that has expired.
• Try to set and follow a routine for taking your medicines.