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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036854
Receipt No. R000041985
Scientific Title Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Date of disclosure of the study information 2019/05/27
Last modified on 2019/05/26

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Basic information
Public title Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Acronym Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Scientific Title Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Scientific Title:Acronym Verification of the impact on sequential therapy Of romosozumab according to the administration period of teriparatide
Region
Japan

Condition
Condition osteoporosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of efficacy and safety treated by Teriparatide less than 6 months administration, romosozumab 12 months administration group, teriparatide 6 months or more but less than 12 months administration, romosozumab 12 months administration group, teriparatide 12 months or more after 24 months administration, romosozumab 12 months administration group in osteoporosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Bone mineral density change up to 12 months before and every 6 months after treatment start
Key secondary outcomes Occurrence of hypocalcemia
Occurrence of other adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Teriparatide less than 6 months, lomosozumab 12 months group
Interventions/Control_2 Teriparatide 6 months or more and less than 12 months group
Interventions/Control_3 Teriparatide 12 to 24 months administration group group
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 1:All osteoporosis patients over 20 years old or older (but does not correspond to the following exclusion criteria)
2:Patients who agree with this study
Key exclusion criteria 1:Patients who are allergic to romosozumab or teriparatide or eldecalcidol
2:Pregnant or breast-feeding patients
3:Patients considered to be at high risk of developing osteosarcoma
4:Patients with primary malignant or metastatic bone tumors
5:Patients with metabolic bone disease other than osteoporosis
6:Patients with unexplained high ALP
7:Others, patients judged by the research director as inappropriate
8:Hypocalcemia (serum corrected calcium level less than 8.0mg/dL)
9:Severe renal failure (less than eGFR15)
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Yukio
Middle name
Last name Nakamura
Organization Shinshu University School of Medicine
Division name Dept. of Orthopaedic Surgery
Zip code 390-8621
Address Asahi 3-1-1, Matsumoto 3908621, Japan
TEL 0263372659
Email yxn14@aol.jp

Public contact
Name of contact person
1st name Yukio
Middle name
Last name Nakamura
Organization Shinshu University School of Medicine
Division name Dept. of Orthopaedic Surgery
Zip code 390-8621
Address Asahi 3-1-1, Matsumoto 3908621, Japan
TEL 0263372659
Homepage URL
Email yxn14@aol.jp

Sponsor
Institute Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
Institute
Department

Funding Source
Organization Shinshu University School of Medicine
Dept. of Orthopaedic Surgery
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 Shinshu University School of Medicine Dept. of Orthopaedic Surgery
Address Asahi 3-1-1, Matsumoto 3908621, Japan
Tel 0263372659
Email yxn14@aol.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
2019 Year 05 Month 27 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
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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 13 Day
Date of IRB
2019 Year 05 Month 13 Day
Anticipated trial start date
2019 Year 05 Month 25 Day
Last follow-up date
2024 Year 05 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 26 Day
Last modified on
2019 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041985

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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