Osteonecrosis Due to Drugs, Jaw Clinical Trial
Official title:
Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction - A Randomized Clinical Trial
The aim of this trial is to evaluate high-dose antiresorptive drug holiday related to tooth
extraction with primary mucosal closure (surgical extraction) including how a drug holiday
affects the health related quality of life.
Research question: Does a drug holiday have any influence on health related quality of life
or the incidence of developing osteonecrosis of the jaw after surgical tooth extraction? The
investigators hypothesize that a drug holiday 1 month before to 3 months after surgical tooth
extraction in cancer patients do not influence the development of osteonecrosis of the jaw
and may even affect the health related quality of life negatively.
Osteonecrosis of the jaw is a known adverse reaction to antiresorptive medication, including
bisphosphonate and denosumab. The globally accepted term is Medication-Related Osteonecrosis
of the Jaws (MRONJ). Since 2003 there has been a worldwide focus at medication-related
osteonecrosis, even though there still exist several of unanswered questions - one of them is
the effect of a drug holiday in relation to tooth extraction. A drug holiday is a temporary
discontinuation of a drug and has been suggested among risk reduction strategies in the
literature. It is still unknown whether a drug holiday plays a significant role in relation
to tooth extraction for the development of osteonecrosis. The investigators want to
investigate the importance of an antiresorptive drug holiday (bisphosphonate, denosumab) in
relation to tooth extraction.
The aim of this trial is therefore to clarify the meaning of high-dose antiresorptive drug
holiday related to tooth extraction with primary mucosal closure in cancer patients and
reveal how a drug holiday affects the health related quality of life. A continuation of the
patients' antiresorptive treatment can possibly lead to increased risk of osteonecrosis of
the jaw, but with the operation procedure with primary closure it is unlikely. It is
beneficial for the cancer patients to continue the high dose antiresorptive therapy because a
drug holiday is a stop in their anti-cancer treatment with risk of increased pain as well as
unwanted skeletal events to occur, and potentially progress of metastases to follow.
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