UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022516
Receipt No. 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 (Ver. 11)

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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
Email 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
Email koji.ishikawa@med.showa-u.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Showa University School of Medicine, Tokyo, Japan
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 ethics committee of the Showa University School of Medicine
Address 1-5-8 Hatanodai, Shinagawa-ku
Tel 03-3784-8022
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025954