Jaw osteonecrosis is quite rare with denosumab treatment

  • Watts NB & al.
  • J Clin Endocrinol Metab
  • 13 Feb 2019

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • With denosumab (e.g., Prolia) therapy for postmenopausal osteoporosis, osteonecrosis of the jaw (ONJ) is quite rare at 5.2 cases for every 10,000 patient-years.
  • Of 11 cases with known outcomes, all healed. 

Why this matters

  • Aging also involves more dental implants, tooth loss and extraction, and jaw surgery. 
  • There are concerns that antiresorptive agents like denosumab might seriously increase ONJ risk.

Key results

  • 45.1% of participants had ≥1 oral procedure/event.
  • Procedure rates were quite similar for continuous denosumab and placebo-to-denosumab groups.
  • Overall ONJ rate was 5.2/10,000 person-years.
  • 12 cases total (all self-report):
    • 10 resolved with treatment.
    • 1 is still in treatment but healing.
    • 1 is unknown, consent withdrawn.
  • Most ONJ followed extractions or bad denture fit.
  • Only 1 ONJ case among 212 patients with dental implants; patient continued denosumab, ONJ healed, implant is still in place.

Study design

  • 7-year extension of randomized, double-blind, placebo-controlled, multinational 3-year FREEDOM trial .
  • 4550 participants from original trial of denosumab (60 mg SQ every 6 months) vs placebo.
  • All continued on denosumab (original treatment group) or started on denosumab (original placebo group) at beginning of 7-year extension period.
  • 3591/4550 completed the oral events survey.
  • Outcome: rates or oral procedures/events, ONJ.
  • Funding: Amgen, Inc.

Limitations

  • Self-reported dental information.

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