Can you give me a patient education summary for Prolia (denosumab) for a post‑menopausal woman with osteoporosis at high fracture risk?

Patient Education Summary: Prolia (Denosumab) for Osteoporosis

What is Prolia and How Does It Work?

Prolia is a medication given as an injection under your skin every 6 months to strengthen your bones and prevent fractures. 1

• Prolia works by blocking a protein called RANKL that causes bone breakdown, helping your bones stay stronger and denser 1, 2
• In clinical trials, Prolia reduced spine fractures by 68%, hip fractures by 40%, and other fractures by 20% over 3 years 1, 3
• Your bone density will increase at the spine, hip, and other sites while taking this medication 1

How You Will Receive Prolia

• You will get a 60 mg injection under your skin (like a flu shot) once every 6 months 4, 1
• The injection is given by your healthcare provider in the office 1
• You must take calcium (at least 1000 mg daily) and vitamin D (at least 400-800 IU daily) supplements every day while on Prolia 1

Important Things You Must Do Before Starting Prolia

You must have a dental checkup before starting Prolia to identify any tooth or gum problems. 5, 6

• Tell your dentist you will be starting Prolia 5
• Complete any needed dental work before beginning treatment 5
• If you have kidney disease, you will need blood tests to check your calcium, vitamin D, and parathyroid hormone levels before starting 1

Common Side Effects

Most people tolerate Prolia well, with side effects similar to placebo in studies. 6, 3

• Joint or muscle pain 5, 6
• Cold symptoms (runny nose, sore throat) 5, 6
• Headache 5, 6
• Back pain 5

Serious Side Effects to Watch For (Rare but Important)

Call your doctor immediately if you experience any of these symptoms: 5, 1

Low Calcium (Hypocalcemia)

• Muscle spasms, twitches, or cramps 1
• Numbness or tingling in fingers, toes, or around your mouth 1
• This is why you must take your calcium and vitamin D supplements every day 1

Jaw Problems (Osteonecrosis of the Jaw)

• Jaw pain, swelling, or numbness 5
• Loose teeth 5
• Sores in your mouth that don't heal 5
• Avoid invasive dental procedures (like tooth extractions or implants) while on Prolia when possible 5
• Maintain excellent oral hygiene with regular brushing and flossing 5

Unusual Thigh, Hip, or Groin Pain

• New or unusual pain in your thigh, hip, or groin could be a warning sign of an atypical fracture 5
• Report any new pain in these areas to your doctor right away 5

Signs of Infection

• Fever or chills 5
• Severe abdominal pain 5
• Painful urination or urinary symptoms 5
• Skin infections, redness, or warmth 5

Skin Reactions

• Severe rash, itching, or blistering 5
• Skin peeling that doesn't resolve 5

Critical Warning: Never Stop Prolia Suddenly

This is the most important thing to understand about Prolia: you cannot simply stop taking it without a plan. 5, 7

• Unlike other osteoporosis medications, Prolia does not stay in your bones after you stop 5, 7
• If you stop Prolia without transitioning to another medication, you are at high risk for multiple spine fractures within 7-19 months 5, 7
• These "rebound" fractures can be severe and involve multiple vertebrae at once 5, 7
• If you need to stop Prolia for any reason, your doctor must immediately start you on another bone medication (usually an IV infusion of zoledronic acid) within 6-7 months of your last Prolia dose 5
• Do not apply the concept of a "drug holiday" to Prolia—this medication requires continuous treatment or immediate transition to another therapy 5

How Long Will You Take Prolia?

• Studies show Prolia is safe and effective for up to 10 years of continuous treatment 5, 3
• Your bone density continues to improve the longer you take it 3
• Most patients with high fracture risk should continue Prolia indefinitely unless there is a specific reason to stop 5
• Your doctor will monitor you with bone density scans every 1-2 years 5

Dental Care While on Prolia

• See your dentist for regular checkups at least once a year 5
• Tell every dentist and oral surgeon that you are taking Prolia 5
• Maintain excellent oral hygiene with daily brushing and flossing 5
• If you need dental surgery, discuss timing with both your dentist and the doctor prescribing Prolia 5

Monitoring and Follow-Up

Your healthcare team will monitor you regularly: 5

• Blood tests to check calcium levels, especially if you have kidney problems 5, 1
• Bone density scans every 1-2 years to track your progress 5
• Regular assessment for any signs of infection, jaw problems, or unusual bone pain 5
• Annual dental examinations 5

When to Call Your Doctor

Contact your healthcare provider immediately if you experience: 5, 1

• Symptoms of low calcium (muscle spasms, numbness, tingling) 1
• Jaw pain, loose teeth, or mouth sores that don't heal 5
• New thigh, hip, or groin pain 5
• Signs of infection (fever, severe abdominal pain, painful urination) 5
• Severe skin reactions 5
• Severe bone, joint, or muscle pain that is new or worsening 5

Special Considerations

• If you have kidney disease: You are at higher risk for low calcium and will need closer monitoring with more frequent blood tests 1
• If you are planning pregnancy: Prolia can harm an unborn baby; discuss birth control and family planning with your doctor 1
• Prolia does not require dose adjustment based on age, making it suitable for older adults 5

Advantages of Prolia

• Only requires an injection every 6 months (not daily or weekly pills) 1, 8
• No need to stay upright or avoid eating/drinking like with oral bisphosphonates 4
• Safe for patients with kidney impairment (unlike some other osteoporosis medications) 4, 5
• Effective for patients who cannot tolerate or have failed other osteoporosis treatments 1

Remember Your Daily Supplements

You must take calcium and vitamin D supplements every single day while on Prolia. 1

• Calcium: at least 1000 mg daily 1
• Vitamin D: at least 400-800 IU daily (your doctor may recommend higher doses) 1
• These supplements help prevent low calcium levels and support bone health 1