UMIN-CTR Clinical Trial

Basic information
Public title	The clinical effect of teriparatide on BRONJ (bisphosphonate-related osteonecrosis of the jaw)
Acronym	The clinical effect of teriparatide on BRONJ
Scientific Title	Study to the clinical effect of teriparatide on BRONJ (bisphosphonate-related osteonecrosis of the jaw)
Scientific Title:Acronym	The clinical effect of teriparatide on BRONJ
Region	Japan

Condition
Condition	bisphosphonate-related osteonecrosis of the jaw
Classification by specialty	Oral surgery Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose is to examine the teriparatide effect on refractory BRONJ with conservative treatment.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of necrotic bone exposure bone formation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	teriparatide(daily)
Interventions/Control_2	teriparatide(weekly)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are eligible for teriparatide treatment for osteoporosis Patients who have been diagnosed with BRONJ Patients refractory to conservative treatment with BRONJ Outpatients Patients with documented consent to participate in this study
Key exclusion criteria	Patients with hypercalcemia Patients who are considered to be at high risk of developing osteosarcoma as follows (a) Patients with Paget's disease of bone (b) Patients with unexplained high alkaline phosphatase levels (c) Young patients whose epiphyseal line has not yet closed (d) Patients who have received radiation therapy that may affect bone in the past. Patients with primary malignant bone tumors or metastatic bone tumors Patients with metabolic bone diseases other than osteoporosis (hyperparathyroidism, etc.) Pregnant women, women who may become pregnant, and lactating women Patients with a history of hypersensitivity to teriparatide components or teriparatide acetate Patients with serious complications such as cancer, cardiac disease, liver disease, and renal disorder Patients currently using an activated vitamin D preparation or a digitalis preparation Patients who are unable to give informed consent Patients who are judged by the physician to be unsuitable for teriparatide treatment
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Daigo Middle name Last name Yoshiga
Organization	Kyshu Dental University
Division name	Oral Medicine
Zip code	803-8580
Address	2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 Japan.
TEL	093-582-1131
Email	r11yoshiga@fa.kyu-dent.ac.jp

Public contact
Name of contact person	1st name Daigo Middle name Last name Yoshiga
Organization	Kyshu Dental University
Division name	Oral Medicine
Zip code	803-8580
Address	2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 Japan.
TEL	093-582-1131
Homepage URL
Email	r11yoshiga@fa.kyu-dent.ac.jp

Sponsor
Institute	Kyushu Dental University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu Dental University
Address	2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka 803-8580 Japan.
Tel	+81 93-582-1131
Email	r11yoshiga@fa.kyu-dent.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	27
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 01 Day
Date of IRB	2014 Year 12 Month 10 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2020 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 27 Day
Last modified on	2020 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048919