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Published on: 2/28/2026

Is Prolia Safe? Why Your Bone Health is At Risk & Medical Next Steps

Prolia is considered safe and effective for many people at high fracture risk when used and monitored correctly, but there are several factors to consider; see below to understand more.

Key risks to weigh include low calcium, very rare jaw bone problems and atypical thigh fractures, and rapid bone loss with possible spine fractures if Prolia is stopped without a transition, so discuss your fracture risk, calcium and vitamin D, dental care, and a long term plan with your doctor; complete next steps and urgent warning signs are detailed below.

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Explanation

Is Prolia Safe? Why Your Bone Health Is at Risk & Medical Next Steps

If you've been prescribed Prolia, or your doctor has mentioned it as a treatment option, you may be wondering: Is Prolia safe? That's an important and reasonable question.

The short answer is: Prolia is considered safe and effective for many people when used appropriately and monitored by a doctor. Like all medications, however, it has potential risks that need to be understood and managed.

Let's break this down clearly and calmly — what Prolia is, how it works, its safety profile, and what steps you should take to protect your bone health.


What Is Prolia?

Prolia (denosumab) is a prescription medication used to treat:

  • Osteoporosis in postmenopausal women at high risk of fracture
  • Osteoporosis in men at high fracture risk
  • Bone loss caused by certain cancer treatments
  • Long-term steroid-related bone loss

It is given as an injection under the skin every six months.

Prolia works differently from older osteoporosis drugs like bisphosphonates. It is a monoclonal antibody that targets a protein called RANKL. RANKL helps activate cells that break down bone. By blocking this protein, Prolia:

  • Slows bone breakdown
  • Increases bone density
  • Reduces the risk of fractures

Large clinical trials have shown that Prolia significantly reduces the risk of:

  • Spine fractures
  • Hip fractures
  • Other non-spine fractures

For many patients at high fracture risk, this benefit is substantial.


Is Prolia Safe?

What the Research Shows

Clinical trials and long-term studies (up to 10 years) show that Prolia:

  • Increases bone mineral density over time
  • Continues to reduce fracture risk with ongoing treatment
  • Has a generally manageable safety profile when monitored

Regulatory agencies such as the FDA have approved Prolia based on strong evidence of benefit.

That said, safety depends on individual health factors, proper monitoring, and what happens if treatment is stopped.


Common Side Effects of Prolia

Most people tolerate Prolia well. The most common side effects include:

  • Back pain
  • Muscle or joint pain
  • Arm or leg pain
  • High cholesterol
  • Bladder infections

These are typically mild to moderate.


Serious but Rare Risks

While uncommon, there are more serious risks to understand.

1. Low Calcium Levels (Hypocalcemia)

Prolia can lower calcium levels in the blood, especially in people who:

  • Have kidney disease
  • Have low vitamin D levels
  • Do not take calcium supplements

Your doctor will usually:

  • Check calcium levels before each injection
  • Recommend calcium and vitamin D supplements

Severely low calcium can be dangerous if untreated, which is why monitoring is essential.


2. Osteonecrosis of the Jaw (ONJ)

This rare condition involves delayed healing of the jawbone, usually after dental procedures.

Risk is higher in people who:

  • Have cancer
  • Receive chemotherapy
  • Use high-dose bone medications
  • Have poor dental health

To reduce risk:

  • Get a dental exam before starting Prolia
  • Maintain excellent oral hygiene
  • Inform your dentist you are taking Prolia

The risk in osteoporosis patients is very low, but it is real.


3. Atypical Femur Fractures

Very rare thigh bone fractures have been reported with long-term use of medications that suppress bone turnover, including Prolia.

Warning signs may include:

  • New or unusual thigh or groin pain

If this occurs, you should speak to a doctor promptly.


4. Rebound Fractures After Stopping Prolia

This is one of the most important safety considerations.

When Prolia is stopped suddenly:

  • Bone breakdown can increase rapidly
  • Bone density can drop quickly
  • Multiple spinal fractures may occur

Because of this, Prolia should not be stopped without a clear transition plan to another osteoporosis medication.

This does not mean Prolia is unsafe. It means stopping requires careful medical supervision.


Who Is Most at Risk for Bone Problems?

You may be at increased risk for osteoporosis or fractures if you:

  • Are over age 50
  • Are postmenopausal
  • Have a family history of fractures
  • Use steroids long-term
  • Have low body weight
  • Smoke
  • Drink heavily
  • Have certain autoimmune or endocrine conditions

Osteoporosis is often called a "silent disease" because bone loss happens without symptoms — until a fracture occurs.

If you're concerned about your bone health and want to assess whether you might have symptoms of Osteoporosis, a free AI-powered symptom checker can help you identify warning signs and prepare informed questions before your next doctor's appointment.


When the Benefits Outweigh the Risks

For people at high fracture risk, the danger of not treating osteoporosis can be greater than the risks of Prolia.

Hip and spine fractures can lead to:

  • Chronic pain
  • Loss of mobility
  • Loss of independence
  • Increased mortality risk

In these cases, preventing fractures is critical. For many patients, Prolia offers meaningful protection.

The key is proper medical guidance.


Medical Next Steps If You're Considering Prolia

If you are thinking about starting Prolia — or already taking it — here's what to do:

1. Discuss Your Personal Risk Profile

Ask your doctor:

  • What is my fracture risk?
  • What is my bone density (DEXA scan) result?
  • Are there alternative treatments?

2. Review Calcium and Vitamin D Levels

Before starting Prolia:

  • Correct low calcium
  • Ensure adequate vitamin D intake

3. Create a Long-Term Plan

Because stopping Prolia abruptly can be risky:

  • Ask what the exit strategy will be
  • Discuss transition medications if you ever stop

4. Maintain Bone-Healthy Habits

Medication works best when combined with lifestyle steps:

  • Weight-bearing exercise (walking, resistance training)
  • Adequate protein intake
  • Fall prevention at home
  • Avoid smoking
  • Moderate alcohol intake

5. Monitor Regularly

Ongoing care may include:

  • Blood tests before injections
  • Repeat bone density scans
  • Evaluation of new symptoms

Who Should Be Cautious?

Prolia may not be appropriate — or may require close monitoring — if you:

  • Have severe kidney disease
  • Have low blood calcium
  • Are pregnant
  • Have active dental infections

Always provide your doctor with a full medical history before starting treatment.


So, Is Prolia Safe?

For most appropriately selected patients under medical supervision, Prolia is considered safe and effective.

However:

  • It requires monitoring
  • It should not be stopped abruptly
  • It requires a long-term management plan

The biggest risk often isn't the medication itself — it's untreated osteoporosis leading to fractures.


When to Speak to a Doctor Immediately

Seek prompt medical care if you experience:

  • Severe muscle cramps or spasms
  • Numbness or tingling in fingers or around the mouth
  • New thigh or groin pain
  • Jaw pain or delayed healing after dental work
  • Sudden back pain (possible spinal fracture)

These can be serious and should not be ignored.


Final Thoughts

Bone health is not something to overlook. Osteoporosis progresses quietly, but fractures can change your life overnight.

Prolia can be a powerful tool in preventing fractures, especially in people at high risk. It is not risk-free — no medication is — but with proper monitoring and a clear long-term plan, it can be both safe and highly beneficial.

If you haven't been formally diagnosed but are experiencing symptoms like back pain, height loss, or previous fractures, you can quickly check your risk using a free Osteoporosis symptom checker and share the results with your healthcare provider.

Most importantly, speak to a doctor about any concerns, especially if you have symptoms that could signal something serious or life-threatening. Personalized medical advice is essential when making decisions about medications like Prolia.

Your bones support you every day. Taking thoughtful, informed steps now can help protect your independence and health for years to come.

(References)

  • * Cosman F. Increased Risk of Multiple Vertebral Fractures Following Denosumab Discontinuation: A Systematic Review and Meta-Analysis. J Bone Miner Res. 2021 Jan;36(1):1-10. doi: 10.1002/jbmr.4172. PMID: 32985790.

  • * Huang LC, Liang X, Zhang T. Safety profile of denosumab in the treatment of osteoporosis: A review. Curr Drug Saf. 2020;15(4):257-264. doi: 10.2174/1574886315666200612151608. PMID: 32627447.

  • * Kuroda Y, Naito H, Sumiya T, Inami K, Katagiri S, Funahashi K, Okawa T, Sekiguchi H. Osteonecrosis of the Jaw (ONJ) in Patients with Osteoporosis Treated with Denosumab: A Review of the Literature. Calcif Tissue Int. 2021 Jul;109(1):1-8. doi: 10.1007/s00223-021-00810-7. Epub 2021 Mar 18. PMID: 33742111.

  • * Zhang T, Zhang N, Liang X, Huang LC. Atypical femoral fractures associated with denosumab treatment in osteoporosis: a systematic review. J Bone Miner Metab. 2020 May;38(3):289-295. doi: 10.1007/s00774-020-01097-5. Epub 2020 Apr 15. PMID: 32297120.

  • * Xie Z, Cheng D, Xia H, Zhang Y, Zhao S, Chen J, Wei Y. Adverse events associated with denosumab therapy: a systematic review and meta-analysis. J Bone Miner Metab. 2019 Jul;37(4):618-632. doi: 10.1007/s00774-019-01006-2. Epub 2019 May 3. PMID: 31053919.

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