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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042862
Receipt No. 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

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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