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Outcome Measures

Primary Outcomes (2)

Development of osteonecrosis of the jaw (ONJ) or incomplete healing at 3 months follow-up
The outcome assessor has 3 options for registration related to ONJ occurrence: * Complete healing = mucosal covering = no sign of ONJ, defined as complete wound healing; Intact mucosa, that is total mucosal covering over the tooth extraction area. * Incomplete healing = presence of fibrin covering partly or over all mucosal operation area; Defined as the presence of fibrin at the surface of the operation area, thus still being a wound. * ONJ present, defined according to the AAOMS position paper 2014 (4), all three items have to be present: 1. Current or previous treatment with antiresorptive agents. 2. Exposed bone or bone that can be probed through an extraoral or intraoral fistula that has persisted for longer than 8 weeks. 3. No history of radiation therapy to the jaws or obvious metastatic disease to the jaws.
3 months follow-up
EQ-5D-5L: Change in patients health related quality of life from allocation/enrollment
The patients are given the EQ-5D-5L questionnaire. The 5-level EQ-5D version (EQ-%D-5L) was introduced by the EuroQol Group in 2009 and consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, serve problems and extreme problems. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The Danish dataset (SPSS syntax crosswalk values EQ-5D-5L Denmark) will be used to analyze patients´ responses.
The patient will be asked to fulfill the EQ-5D-5L at allocation/enrollment and again at 1, 3 and 6 months follow-up.

Secondary Outcomes (3)

Pain from the jaw
This is asked prior to tooth extraction (time 0), at suture removal (time 10-14 days), at 1-month follow-up and at 3 and 6 months follow-up and is registered in the datasheet.
Incidence of unwanted skeletal events
Incidence (number of) unwanted skeletal events during the period and is registered at 3 and 6 months follow-up.
Progression of cancer disease
The patient will be weighted at baseline, time of tooth removal, 1 month follow-up, 3 and 6 months follow-up visit.

Interventions

Continuation of antiresorptives in relation to tooth extraction (surgical tooth removal)Other

We want to investigate the importance of an antiresorptive drug holiday (bisphosphonate, denosumab) in relation to tooth extraction. The experimental intervention in this trial is drug continuation starting before tooth extraction with primary closure. We simply ask the participating cancer patients to continue their high dose antiresorptive treatment for 4 months (intervention-period: 1 month pre-operative, 3 months post-operative) instead of taking a drug holiday.

Cancer patients, randomized A

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

The allocation of the patients is not known to the clinical investigator, the surgeon or the outcome assessor but to the patient's oncologic doctor and nurse, who are in charge of drug delivery, and a supervisor (Klaus Gotfredsen) not involved in any registrations or surgeries. The participating patients will not be blinded. The patients do know which group they are randomized to and therefore do know if they are treated with or without drug holiday during the trial period (1+3 months). The patients are carefully instructed not to reveal which group they belong during the trial to the assessor. Klaus Gotfredsen will make sure that the patients randomized to the intervention group will continue their antiresorptive therapy and the patients randomized to the control group will be treated with drug holiday this in close collaboration with the oncological departments. The medicine will be giving to the patient by the department's nurse.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: This trial is designed as an investigator-initiated, parallel-group, randomized, clinical, single-blinded, trial investigating no antiresorptive drug holiday starting before tooth extraction with primary closure versus antiresorptive drug holiday starting before tooth extraction with primary closure in cancer patients

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

DDS, PhD fellow

Antiresorptive Drug Continuation Compared With Drug Holiday in Cancer Patients Needing Tooth Extraction

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

Cancer patients, randomized A

Cancer patients, randomized B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

Cancer patients, randomized A

Cancer patients, randomized B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations