Glossary

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  • Bone density
    A measure of how much calcium and other types of minerals are present in a section of your bone. Postmenopausal osteoporosis decreases your bone density and makes bone tissue thinner and weaker. Also called bone mineral density.
  • Calcium
    A mineral that makes up a major part of your bones and helps keep them strong.
  • DXA
    A test used to measure bone density. DXA (dual-energy x-ray absorptiometry) testing is fast, accurate, pain-free, and uses very little radiation.
  • Fracture
    A break in a bone—either complete or partial.
  • Muscle-strengthening exercise
    Exercise in which you are moving parts of your body, weights, or other resistance against gravity.
  • Osteoporosis
    A disease in which the bones become thin and weak, putting you at risk for breaking a bone. Osteoporosis usually causes no symptoms until a fracture happens.
  • Postmenopausal
    After menopause ("change of life").
  • Risk factor
    A quality or activity that affects your risk. You can control some risk factors (such as smoking), but not others (such as family medical history).
  • Supplement
    A dietary supplement is a vitamin or mineral taken in a non-food form (such as a pill – e.g. vitamin D or calcium).
  • Symptom
    An effect of a disease or condition that you can see or feel. Osteoporosis usually has no symptoms until a fracture happens.
  • T-score
    A key measure of bone density reported on a DXA scan, which compares your bone density to the bone density of a healthy, young adult woman.
  • Vitamin D
    A nutrient that enables your body to absorb calcium. It can be obtained from sunlight, food, or supplements.
  • Weight-bearing exercise
    Exercise in which you are bearing your body’s weight on your feet and legs, as your muscles and bones work against gravity.
Indication  Prolia® (denosumab) is a prescription medicine used to treat osteoporosis in women after menopause who:
  • are at high risk for fracture, meaning women who have had a fracture related to osteoporosis, or who have multiple risk factors for fracture
  • cannot use another osteoporosis medicine or other osteoporosis medicines did not work well
Important Safety Information

Do not take Prolia® if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia® may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia®.

What is the most important information I should know about Prolia®?

If you receive Prolia®, you should not receive XGEVA®. Prolia® contains the same medicine as XGEVA® (denosumab).

Prolia® (denosumab) can cause serious side effects:

Low blood calcium (hypocalcemia). Prolia® may lower the calcium levels in your blood. If you have low blood calcium, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia®.

Take calcium and vitamin D as your doctor tells you to help prevent low blood calcium.

Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia®. You may need to go to the hospital for treatment.

Prolia® is a medicine that may affect your immune system. People who have weakened immune systems or take medicines that affect the immune system may have an increased risk for developing serious infections.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Severe jaw bone problems (osteonecrosis) may occur. Your doctor should examine your mouth before you start Prolia® and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia®.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Before taking Prolia® (denosumab), tell your doctor if you:

  • Take the medicine XGEVA® (denosumab).
  • Have low blood calcium.
  • Cannot take daily calcium and vitamin D.
  • Had parathyroid or thyroid surgery (glands located in your neck).
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome).
  • Have kidney problems or are on kidney dialysis.
  • Plan to have dental surgery or teeth removed.
  • Are pregnant or plan to become pregnant.
  • Are breast-feeding or plan to breast-feed.

What are the possible side effects of Prolia®?

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

These are not all the possible side effects of Prolia®. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

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.