UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022516 |
|---|---|
| Receipt number | R000025954 |
| Scientific Title | The potential role of BTMs in the prediction of hypocalcemia induced by denosumab in patients with bone metastases. |
| Date of disclosure of the study information | 2016/05/29 |
| Last modified on | 2020/04/12 00:10:29 |
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Basic information
Public title
The potential role of BTMs in the prediction of hypocalcemia induced by denosumab in patients with bone metastases.
Acronym
The potential role of BTMs in the prediction of hypocalcemia induced by denosumab in patients with bone metastases.
Scientific Title
The potential role of BTMs in the prediction of hypocalcemia induced by denosumab in patients with bone metastases.
Scientific Title:Acronym
The potential role of BTMs in the prediction of hypocalcemia induced by denosumab in patients with bone metastases.
Region
| Japan |
Condition
Condition
Bone metastases
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Orthopedics |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Whether bone turnover markers is useful as prediction marker of hypocalcemia induced by denosumab.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of the risk factors associated with hypocalcemia induced by denosumab using bone turnover markers.We evaluate the correlations between bone turnover markers at baseline and change the value of the serum Ca from baseline to nadir in 3 months after administration of denosumab.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
We check the time course of calcium concentrations and risk factors for hypocalcemia in patients recieving denosumab. The follow-up period is three months after recieving densoumab.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ptienta are eligible for this study if they were
(1)The patients who plan to use the denosumab for bone metastases.
(2)The patient who approves participation to the clinical research.
Key exclusion criteria
Patients were excluded from the study if they had
(1)contraindicate factors
(2)hyperparathyroidism or under the pregnacy.
(3)adjusted baseline serum calcium concentrations above or below the normal range in our laboratory.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ishikawa |
Organization
Showa University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
142-8666
Address
Department of Orthopaedic Surgery, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8543
katsu@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ishikawa |
Organization
Showa University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8543
Homepage URL
koji.ishikawa@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Showa University School of Medicine, Tokyo, Japan
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
ethics committee of the Showa University School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku
Tel
03-3784-8022
gakuji@ofc.showa-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Ishikawa K, Nagai T, Tuchiya K, et al. High bone turnover status as a risk factor for symptomatic hypocalcemia following denosumab treatment in patients with osteoporosis. Clin Interv Aging. 8;13:1929-1934.2018.
Results date posted
| 2020 | Year | 04 | Month | 12 | Day |
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
| 2015 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 02 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 02 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 02 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025954
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