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J Clin Endocrinol Metab. 2019 Feb 13. doi: 10.1210/jc.2018-01965. [Epub ahead of print]

Invasive Oral Procedures and Events in Women With Postmenopausal Osteoporosis Treated With Denosumab for up to 10 Years.

Author information

1
Mercy Health, Cincinnati, OH, USA.
2
Columbia University, New York, NY, USA.
3
University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
4
Leiden University Medical Center, Leiden, The Netherlands.
5
Amgen Inc., Thousand Oaks, CA, USA.
6
Oregon Osteoporosis Center, Portland, OR, USA.
7
Australian Catholic University, Melbourne, VIC, Australia.

Abstract

Context:

Antiresorptive therapy has been associated with osteonecrosis of the jaw (ONJ), an infrequent but potentially serious adverse event.

Objective:

To assess information on invasive oral procedures and events (OPEs) - dental implants, tooth extraction, natural tooth loss, scaling/root planing, jaw surgery - during the 7-year FREEDOM Extension and to present details of positively adjudicated ONJ cases.

Design:

Randomized, double-blind, placebo-controlled 3-year trial (FREEDOM) followed by 7 years of open-label denosumab (FREEDOM Extension). At Extension Year 3, women were asked to record their history of invasive OPEs since the start of the Extension to Year 2.5 and oral events in the prior 6 months. The questionnaire was then administered every 6 months (Q6M) until the end of the Extension.

Setting:

Multicenter, multinational clinical trial.

Patients:

Women with postmenopausal osteoporosis.

Interventions:

Subcutaneous denosumab 60mg or placebo Q6M for 3-years, then 7 years of open-label denosumab.

Main Outcome Measures:

Self-reports of OPEs and adjudicated cases of ONJ.

Results:

45.1% of respondents reported at least one invasive OPE. The exposure-adjusted ONJ rate in FREEDOM Extension was 5.2 per 10,000 subject-years. ONJ incidence was higher in those reporting an OPE (0.68%) than not (0.05%).

Conclusions:

While invasive OPEs were common in these denosumab-treated women and were associated with an increased ONJ incidence, the overall rate of ONJ was low, and all cases with complete follow-up resolved with treatment.

PMID:
30759221
DOI:
10.1210/jc.2018-01965

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