Prolia (Denosumab) for Osteoporosis

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Prolia (denosumab) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat osteoporosis in women after menopause who are at high risk for fracture. It is also approved to increase bone mass in men with osteoporosis who are at high risk for fracture.

What Members Say

MHT logo These insights are based on 12,532 comments about Prolia from MyOsteoTeam members. These are the experiences of a small number of people and are not meant to be medical advice.

Benefits:

Twice-yearly dosing feels simpler than weekly or monthly osteoporosis medicines.
Bone density often improves or stays stable on follow-up DEXA scans.
The injection can feel easier to tolerate than oral medicines that upset the stomach.

Considerations:

Stopping, skipping, or delaying a dose can raise the risk of spinal fractures.
Jaw problems and dental work require extra planning and close communication with dentists.
Bone, joint, muscle, thigh, hip, or groin pain can occur during treatment.

How Prolia Works and How It’s Taken

Prolia is a type of medicine called a RANK ligand (RANKL) inhibitor. It blocks a protein called RANKL that helps control cells that break down bone. By blocking this protein, Prolia slows bone breakdown and helps increase bone mass and strength.

Doctors prescribe Prolia to:

Treat osteoporosis in women after menopause who are at high risk for fracture. This includes women who have had an osteoporosis-related fracture, have several fracture risk factors, or cannot use or did not respond to other available osteoporosis treatments.
Increase bone mass in men with osteoporosis who are at high risk for fracture.
Treat osteoporosis caused by glucocorticoid medicines, such as prednisone, in men and women who are at high risk for fracture and are expected to take these medicines for at least six months.
Increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for prostate cancer that has not spread to other parts of the body.
Increase bone mass in women at high risk for broken bones who are receiving adjuvant aromatase inhibitor therapy, which is a treatment used as part of breast cancer care.

Prolia is given as an injection under the skin by a healthcare provider once every six months.

Typical Dosing for Osteoporosis

The recommended dose of Prolia is 60 milligrams given as an injection under the skin once every six months.

People should receive 1,000 milligrams of calcium each day and at least 400 international units of vitamin D each day while receiving Prolia.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Top Advice From Members on Prolia

These insights are based on 12,532 comments about Prolia from MyOsteoTeam members. These are the experiences of a small number of people and are not meant to be medical advice.

Members who use Prolia often say it helps to stay on schedule, keep up with follow-up care, and pay attention to how your body feels after each shot. Many also mention talking with their doctor about dental work, calcium checks, side effects, and what the plan would be if treatment ever needs to change.

1
Talk to your doctor before stopping or delaying a dose.
“I had eight compression fractures because my primary care provider said it was OK to skip a dose of Prolia to see if I had a side effect I thought I had. It was not OK to skip.”
2
Keep up with dental checkups and discuss dental work early.
“Make sure to have a good dental checkup and care before starting treatment.”
3
Be patient and follow your progress over time.
“My last bone density test actually showed that I had built some bone too. Not a ton, but some, which is better than going the other direction.”

Connect with others who understand life with osteoporosis. Join MyOsteoTeam for free.

Prolia Side Effects

In clinical studies of Prolia, the most common side effects differed depending on why people were taking it.

In women with osteoporosis after menopause, common side effects include:

Back pain
Pain in the arms or legs
High cholesterol
Cystitis (bladder infection)
Muscle or bone pain

In men with osteoporosis, common side effects include:

Back pain
Nasopharyngitis, such as a runny nose or sore throat
Joint pain

In people with osteoporosis caused by corticosteroid medicines, common side effects include:

Back pain
High blood pressure
Bronchitis
Headache

In people with bone loss related to certain prostate or breast cancer treatments, side effects include:

Joint pain
Back pain
Pain in the arms or legs
Muscle or bone pain

Serious Side Effects and Warnings

Prolia can cause serious side effects that may require immediate medical attention. These include:

Severe hypocalcemia — Dangerously low calcium levels in the blood can cause muscle spasms, cramps, or tingling; risk is higher with advanced chronic kidney disease.
Serious allergic reactions — These reactions can include anaphylaxis, which can cause trouble breathing, hives, low blood pressure, or swelling of the face, lips, or tongue.
Osteonecrosis of the jaw — Jawbone damage can cause jaw pain or slow healing in the mouth, often after dental work.
Atypical femur fractures — Unusual thigh bone fractures can cause new or unusual hip, groin, or thigh pain.
Multiple vertebral fractures after stopping Prolia — Increased risk of spine fractures can occur after discontinuation.
Serious infections — Skin infections can occur, such as cellulitis and infections that may require hospitalization.
Skin reactions — Dermatitis, eczema, or rash can occur and may be serious.
Severe musculoskeletal pain — Severe bone, joint, or muscle pain may be disabling.

Get medical help right away if you think you are having a serious reaction.

This drug has a boxed warning, the FDA’s strongest safety warning, for some of the serious risks mentioned above. A boxed warning does not mean the drug is unsafe for everyone or that everyone faces the same level of risk.

How To Save on Prolia

Amgen Inc, the manufacturer of Prolia, offers the Amgen SupportPlus Co-Pay Program. Eligible people with commercial insurance may pay as little as $0 out of pocket for each dose.

The program can also be applied to deductibles, coinsurance, and copayments.

To learn more, visit the Amgen SupportPlus Co-Pay Program website or call 866-264-2778.

What To Know Before Taking Prolia

Before you start Prolia:

Your doctor should make sure your blood calcium is not too low.
If you have advanced chronic kidney disease, your doctor should also check for a bone and mineral problem linked to kidney disease. This may include tests for parathyroid hormone, calcium, and vitamin D.
If you can become pregnant, your healthcare provider should do a pregnancy test before you receive Prolia.

Before taking Prolia, tell your doctor if you:

Are taking another medicine that contains denosumab
Have low blood calcium
Cannot take calcium and vitamin D every day
Have had thyroid or parathyroid surgery
Have trouble absorbing minerals from your stomach or intestines
Have kidney problems or are on dialysis
Take medicines that can lower your blood calcium
Plan to have dental surgery or a tooth removed
Are allergic to denosumab products or any of the ingredients in Prolia

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Take good care of your teeth and gums while receiving Prolia. Brush and floss regularly, and tell your dentist that you receive Prolia before having dental work.

Do not take Prolia if you:

Have low blood calcium
Are pregnant
Have had a serious allergic reaction to Prolia or one of its ingredients

If you miss a dose, get the injection as soon as possible. After that, your next dose should be scheduled six months from the date of your last injection.

Do not take Prolia if you are pregnant because it may harm your baby. If you can become pregnant, use effective birth control during treatment and for at least five months after your last dose. Tell your doctor right away if you become pregnant during treatment.

If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if Prolia passes into breast milk. Do not breastfeed while receiving Prolia.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Prolia for osteoporosis?

In a three-year study of women with osteoporosis after menopause:

New spine fractures occurred in 2.3 percent of women taking Prolia compared with 7.2 percent taking placebo.
Hip fractures occurred in 0.7 percent of women taking Prolia compared with 1.2 percent taking placebo.
Fractures outside the spine occurred in 6.5 percent of women taking Prolia compared with 8.0 percent taking placebo.
At three years, Prolia increased bone mineral density compared with placebo by 8.8 percent at the lower spine, 6.4 percent at the total hip, and 5.2 percent at the femoral neck.

In a separate one-year study of men with osteoporosis:

Prolia increased bone mineral density compared with placebo by 4.8 percent at the lower spine.
Bone mineral density increased by 2.0 percent at the total hip.
Bone mineral density increased by 2.2 percent at the femoral neck.

How long does Prolia take to work for osteoporosis?

Studies show that Prolia starts affecting bone breakdown soon after treatment. A marker of bone breakdown called serum type 1 C-telopeptide decreased by about 85 percent within three days. The largest decreases were seen by one month.

In women with osteoporosis after menopause, Prolia significantly reduced new spine fractures at one, two, and three years. It also significantly increased bone mineral density at the bone sites measured after three years.

The study does not say exactly when a person will notice Prolia working.

Does Prolia interact with other medicines?

Prolia should not be used with other medicines that contain denosumab. Some medicines that lower calcium levels, including a type called calcimimetics, may increase the risk of low blood calcium. Tell your doctor about all medicines, vitamins, and supplements you take before starting Prolia.