What are the recommendations for patients taking Prolia (denosumab) who require dental surgery?

Management of Patients on Denosumab (Prolia) Requiring Dental Surgery

Patients taking denosumab (Prolia) who require dental surgery should have a comprehensive oral examination before starting therapy, avoid invasive dental procedures during treatment when possible, and if dental surgery is necessary, consider temporarily discontinuing denosumab with procedures ideally performed 5-6 months after the last dose and at least 1 month before the next scheduled dose.

Risk Assessment and Prevention

Before Starting Denosumab

• Conduct a thorough oral examination and appropriate preventive dentistry prior to initiating denosumab 1
• Address all modifiable risk factors for medication-related osteonecrosis of the jaw (MRONJ) 2:
  • Poor oral health
  • Ill-fitting dentures
  • Uncontrolled diabetes mellitus
  • Tobacco use
• Complete all necessary invasive dental procedures before starting denosumab therapy 2

Risk Factors for MRONJ

• The risk of MRONJ in patients on denosumab for osteoporosis is approximately 2.3%, which is significantly higher than with oral bisphosphonates (0.1-0.3%) 3
• Risk increases with:
  • Duration of therapy
  • Higher number of extractions 3
  • Early resumption of denosumab after dental procedures 3
  • History of tooth extraction or poor oral hygiene 1
  • Concomitant use of immunosuppressive therapy, angiogenesis inhibitors, or systemic corticosteroids 1

Management Protocol for Dental Surgery

For Elective Dental Procedures

• Elective dentoalveolar surgical procedures (non-medically necessary extractions, alveoloplasties, implants) should be avoided during active therapy with bone-modifying agents 2
• If possible, schedule invasive dental procedures during a "window of opportunity" in the denosumab dosing cycle:
  • Ideally 5-6 months after the last dose of denosumab (60 mg) 4, 3
  • At least 1 month before the next scheduled dose 4
  • Consider delaying the next dose by 1 month if dental surgery is required 4

For Necessary Dental Surgery

1. Consultation and Planning:

   • Consult with the prescribing physician before any invasive dental procedure 2
   • Evaluate the benefit-risk ratio of the procedure with the patient and oncology team 2

2. During Dental Surgery:

   • Use prophylactic antibiotics when tooth extraction cannot be avoided 2
   • Implement meticulous surgical technique with primary wound closure when possible

3. Post-Surgical Follow-up:

   • Evaluate patients systematically every 6-8 weeks until full mucosal coverage of the surgical site 2
   • Communicate with the oncologist regarding healing status, particularly when considering future use of denosumab 2

Special Considerations

Patients with Cancer vs. Osteoporosis

• Patients receiving denosumab for cancer (120 mg every 4 weeks) have a higher risk of MRONJ than those receiving it for osteoporosis (60 mg every 6 months) 5
• For patients with cancer receiving denosumab at oncologic doses, there is insufficient evidence to support or refute the need for discontinuation before dental surgery 2

Dental Implants

• Dental implant treatment may be a triggering factor for osteonecrosis around dental implants 6
• Exercise caution when considering dental implant treatment in patients taking denosumab 6

Monitoring After Denosumab Discontinuation

• Never stop denosumab abruptly due to its reversible mechanism of action and risk of rebound bone turnover 5
• Monitor for hypercalcemia following treatment discontinuation 1
• Be aware of the risk of multiple vertebral fractures after discontinuation 7

Calcium and Vitamin D Management

• Ensure adequate calcium (1,200-1,500 mg daily) and vitamin D3 (700-800 IU daily) supplementation 5
• Correct pre-existing hypocalcemia prior to denosumab treatment 1
• Monitor calcium levels throughout therapy, especially in the first weeks 1

By following these guidelines, clinicians can minimize the risk of MRONJ while providing necessary dental care to patients on denosumab therapy. The timing of dental procedures in relation to denosumab dosing is critical for reducing complications.