UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042862
Receipt number R000048919
Scientific Title Study to the clinical effect of teriparatide on BRONJ (bisphosphonate-related osteonecrosis of the jaw)
Date of disclosure of the study information 2020/12/27
Last modified on 2020/12/27 10:52:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Kyushu Dental University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048919


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name