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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009132
Receipt No. 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

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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
Email 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
Email yumiko@med.kagawa-u.ac.jp

Sponsor
Institute Faculty of Medicine, Kagawa 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 Kagawa University Hospital
Address 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan
Tel 087-891-2011
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010706

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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