UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009132 |
|---|---|
| Receipt number | R000010706 |
| Scientific Title | Study to the effect of teriparatide formulation Forteo versus Teribon on bisphosphonate-related osteonecrosis of the jaw in osteoporosis patients. |
| Date of disclosure of the study information | 2012/10/17 |
| Last modified on | 2020/04/24 14:03:02 |
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Basic information
Public title
Study to the effect of teriparatide formulation Forteo versus Teribon on bisphosphonate-related osteonecrosis of the jaw in osteoporosis patients.
Acronym
Comparative study of teriparatide formulation Forteo versus Teribon on bisphosphonate-related osteonecrosis of the jaw
Scientific Title
Study to the effect of teriparatide formulation Forteo versus Teribon on bisphosphonate-related osteonecrosis of the jaw in osteoporosis patients.
Scientific Title:Acronym
Comparative study of teriparatide formulation Forteo versus Teribon on bisphosphonate-related osteonecrosis of the jaw
Region
| Japan |
Condition
Condition
bisphosphonate-related osteonecrosis of the jaw
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
pain
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Forteo (teriparatide formulation)
Interventions/Control_2
Teribone (teriparatide formulation)
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
Female
Key inclusion criteria
1)The patients who require continued treatment for osteoporosis.
2)female patients with bisphosphonate-related osteonecrosis of the jaw.
3)the stage of bisphosphonate-related osteonecrosis of the jaw is 2 or more.
4)outpatients.
5)Signed informed consent forms are obtained by the patients.
Key exclusion criteria
1) Hypercalcemic disorders
2)Potential risk of osteocarcoma
(1)Patients with Paget's disease of bone
(2)Unexplained elevations of alkaline phosphatase.
(3)Young adult patients with open epiphyses.
(4)Patients with prior external beam or implant radiation involving the skeleton.
3)Patients with bone metastases, history of skeletal malignancies.
4)Metabolic bone diseases other than osteoporosis.
5)Pregnancy or women with suspected pregnancy.
6)Patients with hypersensitivity to teriparatide or to any of its excipients.
7)Serious cardiac disease, serious hepatic disorder , renal disease.
8)Use of active vitamin D3 or Digoxin.
9)The patients who could not be provided with informed consent.
10)Unsuitability for the trial based on clinical judgement.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | OHBAYASHI |
Organization
Kagawa University
Division name
Department of Oral and Maxillofacial Surgery, Faculty of Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture 761-0793, Japan
TEL
087-891-2227
yumiko@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | OHBAYASHI |
Organization
Kagawa University
Division name
Department of Oral and Maxillofacial Surgery, Faculty of Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture 761-0793, Japan
TEL
087-891-2227
Homepage URL
yumiko@med.kagawa-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kagawa 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
Kagawa University Hospital
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan
Tel
087-891-2011
kenkyu@med.kagawa-u.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
香川大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31768589/?from_term=kagawa+ohbayashi&from_pos=7
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31768589/?from_term=kagawa+ohbayashi&from_pos=7
Number of participants that the trial has enrolled
13
Results
TPTD treatment with MRONJ led to partial remission or complete remission in 5 daily-group patients and 3 weekly-group patients. The MRONJ stage was significantly improved from baseline to 6 months of treatment in the entire series of 12 patients (p = 0.008); the weekly group did not show significant improvement, but the daily group did (p = 0.01).
Results date posted
| 2020 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The 13 patients, including 5 rheumatoid arthritis (RA) patients, were adult females with MRONJ that was due to BP therapy for osteoporosis.
Participant flow
We enrolled 13 patients and randomly assigned them to receive either of two treatments: 1/week TPTD injection for 6 months (weekly group; n = 6 patients after 1 dropout), or TPTD injection daily for 6 months (daily group; n = 6 patients). Patients in both groups received conventional therapy plus intensive antibiotic therapy as necessary.
Adverse events
-
Outcome measures
We compared the changes in the patients' clinical stage of MRONJ, bone metabolism, percentage of bone formation, and bone turnover markers between the weekly and daily groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 17 | Day |
Last modified on
| 2020 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010706
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| Registered date | File name |
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