Understanding Osteoporosis

Causes and Symptoms

It is important to know that bones are made up of living tissue that renews itself in a continual process. This renewal process is your bones' natural repair cycle.

The process of bone renewal is similar to filling in potholes on a road. First, existing bone tissue is broken down and removed by bone-resorbing cells, leaving tiny pits behind. Then, bone-forming cells lay down new bone tissue to fill in these pits.

However, as we age, the breaking down of bone tissue may begin to outpace the creation of new bone. Over time, this may make bones thinner, potentially putting you at greater risk for a fracture.

You cannot feel osteoporosis happening in your body. That's why it's important to talk to your doctor to know if you're at risk.

Unfortunately, you cannot feel this happening in your body. It feels no different to have thinner bones than it does normal bones. This lack of symptoms is why osteoporosis is often called a “silent” disease. You may not even know you have osteoporosis until you break a bone or a test reveals you have low bone mineral density.

The only way to know if you have osteoporosis is to take a test that your doctor can prescribe. This will be discussed in a moment. It’s important to understand osteoporosis.

Osteoporosis is a serious disease, not just a normal part of aging. And while osteoporosis is not a sudden disease, it’s important to be proactive and know the signs and symptoms of osteoporosis in order to reduce your risk of fracture due to osteoporosis.

Decreased Estrogen Causes Bone Loss: Since the hormone estrogen helps protect against bone loss, less estrogen in your body results in more bone loss. That's why the years after menopause—when a woman's ovaries stop producing estrogen—is the time of life when bone loss is most rapid.

Men are also susceptible to bone loss later in life because of loss of testosterone, genetic factors, and aging.

Osteoporotic Bones Can Break Easily: Osteoporotic bones are thin and fragile, and can break easily. Fractures can occur in almost any bone, and once you have one, your risk of having more fractures increases. Without proper treatment, osteoporosis can progress and fractures can occur without you even noticing them. One vulnerable area is your spine. Common signs of a fracture in your spine include:

  • Height loss
  • Curvature of the spine

Diagnosing Osteoporosis

Terms Your Doctor May Use:

One phrase you may hear when learning about osteoporosis is "T-score." A T-score is a common measure of bone health. Your T-score is the result from a bone mineral density (BMD) test. Most BMD tests are given through use of a DXA scan.

Because T-scores are commonly reported as negative numbers, it can sometimes be confusing to understand what your T-score means. The greater the negative number, the lower your bone mineral density. For example, a T-score of -3.5 is worse than a T-score of -2.5. A person with a T-score of -2.5 or more is considered to have osteoporosis.

T-scores

Talk to your doctor for more information about a BMD test and your T-score.

Indications for FORTEO:
  • FORTEO® (teriparatide [rDNA origin] injection) is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones (fractures).
  • FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures).
  • FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who can not use other osteoporosis treatments.

FORTEO is a prescription medicine given as a 20 microgram once-daily dose available in a 2.4 mL delivery device for subcutaneous injection over 28 days.

Important Safety Information about FORTEO

What is the most important information I should know about FORTEO?

WARNING: POTENTIAL RISK OF OSTEOSARCOMA

During the drug testing process, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget’s disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy.

Who should not take FORTEO?

  • You should not take FORTEO for more than 2 years over your lifetime.
  • Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.

What should I tell my healthcare provider before taking FORTEO?

  • Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.
  • You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.

What are the possible side effects of FORTEO?

  • FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
  • Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising. These are not all the possible side effects of FORTEO. You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional safety information about FORTEO

  • There is a voluntary patient registry for people who take FORTEO. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to www.forteoregistry.org.
  • The FORTEO Delivery Device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO Delivery Device to give your injection the right way. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Do not inject all the medicine in the FORTEO Delivery Device at any one time. Do not transfer the medicine from the FORTEO Delivery Device to a syringe. This can result in taking the wrong dose of FORTEO. If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.

How should I store FORTEO?

  • Keep your FORTEO Delivery Device in the refrigerator between 36° to 46°F (2° to 8°C). Do not freeze the FORTEO Delivery Device. Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO Delivery Device after 28 days even if it has medicine in it (see the User Manual).

TE Con ISI 07Mar2011

Please see Important Safety Information, including Boxed Warning regarding osteosarcoma above, full Prescribing Information, and Medication Guide.

See FORTEO Delivery Device User Manual that accompanies the Delivery Device.