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 |
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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
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
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
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
