UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030916 |
|---|---|
| Receipt number | R000035303 |
| Scientific Title | The evaluation of bone mineral density in long-term survival patients after allogeneic hematopoietic stem cell transplantation: cross sectional study by KSGCT |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/03/25 10:37:11 |
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Basic information
Public title
The evaluation of bone mineral density in long-term survival patients after allogeneic hematopoietic stem cell transplantation: cross sectional study by KSGCT
Acronym
The evaluation of bone mineral density in long-term survival patients after allogeneic hematopoietic stem cell transplantation: KSGCT1701(Bone-Dx)
Scientific Title
The evaluation of bone mineral density in long-term survival patients after allogeneic hematopoietic stem cell transplantation: cross sectional study by KSGCT
Scientific Title:Acronym
The evaluation of bone mineral density in long-term survival patients after allogeneic hematopoietic stem cell transplantation: KSGCT1701(Bone-Dx)
Region
| Japan |
Condition
Condition
Hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are to measure the bone mineral density of patients who have been disease-free surviving for more than 2 years after allogeneic hematopoietic stem cell transplantation, to analyze the effect of patient characteristics, underlying diseases, immunosuppressive drugs, and post-transplant complications on bone mineral density, and to evaluate the necessity of therapeutic intervention for loss of bone mineral density.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of osteoporosis( score =< -2.5)after allogeneic hematopoietic stem cell transplantation
Key secondary outcomes
1) The prevalence of osteopenia(-2.5 < T score =< -1.0)after allogeneic hematopoietic stem cell transplantation
2) The effect of patient characteristics on osteopenia or osteoporosis
3) The effect of menses discontinuation on osteopenia or osteoporosis
4) The effect of post-transplant complication such as GVHD (graft versus host disease) on osteopenia or osteoporosis
5) The effect of therapeutic intervention on osteopenia or osteoporosis
6) The effect of SRE (skeletal related events) on osteopenia or osteoporosis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients'age >= 20 years at the time of investigation
2) Patients with disease-free surviving for 2 to 5 years after transplant
3) Not exclude patients with their history of skeletal related events
4) Patients who were informed and concented
Key exclusion criteria
1) Patients who are otherwise classified as unfit by the attending physicians for this research.
2) Patients who underwent allogeneic and/or autologous transplantation more than once
3) Patients with multiple myeloma
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Kanto Study Group for Cell Therapy
Division name
Chairman
Zip code
Address
Tokyo
TEL
03-6225-2040
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIROTO ISHII |
Organization
The Jikei university school of medicine
Division name
Department of Clinical Oncology and Hematology
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-Ku, Tokyo
TEL
03-3433-1111
Homepage URL
h-ishii@jikei.ac.jp
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
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
Address
Tel
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
| 2018 | Year | 04 | Month | 01 | 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
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
With ongoing clinical studies on the pharmacological intervention for decrease of bone mineral density following allogeneic hematopoietic stem cell transplantation, the efficacy of bisphosphonate has been reported. As bisphosphonates can be injected, they can be administered even in the presence of gastrointestinal disturbance caused by graft-versus-host disease (GVHD). Kananen et al. conducted a comparative trial of a group of patients who received a vitamin D and calcium preparation with pamidronate following allogeneic transplantation and a group of patients who received it without pamidronate to assess the preventive effects of pamidronate on bone mineral loss. The result revealed that the bone mineral density of the lumbar spine was maintained, thereby demonstrating the preventive effects of pamidronate; however, its effects on the femoral neck were insufficient. Nevertheless, the clinical trial of zoledronic acid indicated that it effectively enhanced the bone mineral density of not only the lumbar spine but also the femoral neck.
Studies from the foreign countries have reported that renal dysfunction, administration of calcineurin inhibitors and steroids, hypogonadism, GVHD, and high risk of fracture represented by the World Health Organization Fracture Risk Assessment scores are some of the causes of bone mineral loss following allogeneic transplantation. However, till date, no study in Japan has reported osteopenia and/or osteoporosis following transplantation. Thus, it is essential to investigate whether these risk factors also apply to Japanese patients. Hence, a group of researchers assessed the bone mineral density of patients who underwent allogeneic transplantations to plan an observational study to evaluate the post-transplant bone mineral density. Elucidating risk factors should facilitate the assessment of whether therapeutic interventions are required to counter declines in post-transplant bone mineral density.
Management information
Registered date
| 2018 | Year | 01 | Month | 21 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035303
