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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046026
Receipt No. R000052514
Scientific Title TWICE-Follow up study
Date of disclosure of the study information 2021/11/15
Last modified on 2021/11/10

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Basic information
Public title TWICE-Follow up study
Acronym TWICE-Follow up study
Scientific Title TWICE-Follow up study
Scientific Title:Acronym TWICE-Follow up study
Region
Japan

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

Objectives
Narrative objectives1 This study enrolls patients with primary osteoporosis who received teriparatide agents for 48 weeks as a early-stage treatment for osteoporosis and who were able to be followed up on the subsequent treatment for 24 months. The purpose of this study is to clarify the effects of different treatment methods after teriparatide agents by investigating the bone mineral density of patients, 3D-shaper evaluation, changes in bone turnover markers, and the occurrence of new fractures. In addition, the purpose is to examine the difference in prognosis between twice-weekly teriparatide and once-weekly teriparatide.(early-stage treatment: twice-weekly teriparatide or once-weekly teriparatide.)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in rate of change in lumbar spine bone mineral density from the start of early-stage treatment to 24 months later of late-stage treatment (grouped by treatment method)
Key secondary outcomes (1) Group by early-stage treatment and late-stage treatment, and calculate summary statistics within groups (a) and (b) for each of the following indicators (A), (B), and (C). In addition, anterior-posterior comparison within the group and a comparison between the groups are performed.
(2) Calculate summary statistics for each of the following indicators (D) and (E) from before the start of pretreatment to 24 months after the start of posttreatment. In addition, comparison between groups is performed.

(A) Bone mineral density (lumbar spine, proximal femur total, femoral neck)
(B) Bone turnover markers (TRACP-5b, P1NP, u-NTX, OC, CTX)
(C) Femoral cortical bone analysis by 3D-shaper
(D) New fracture
(E) Adverse events for which a causal relationship cannot be denied

(a) The amount of change and rate of change of followings: starting from before the start of early-stage treatment to the end of early-stage treatment; starting from before the start of early-stage treatment to 12 months after the start of late-stage treatment; starting from before the start of early-stage treatment to 24 months after the start of late-stage treatment.

(b) The amount of change and rate of change of followings: starting from the start of late-stage treatment to 12 months after the start of late-stage treatment and 24 months after the start of late-stage treatment.

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who participate in the clinical trial (JapcCTI-16377) between January 2017 and July 2017, and received teriparatide agents for 48 weeks.
(2) Patients who could be followed for another 24 months after the above clinical trial was completed.
Key exclusion criteria (1) Patients who have been denied data use by opt-out
(2) Patients who are judged to be inappropriate by the investigator or researcher
Target sample size 82

Research contact person
Name of lead principal investigator
1st name Hidehiro
Middle name
Last name Matsumoto
Organization Sanzai Hospital
Division name orthopedics
Zip code 881-0113
Address 2278, Ooaza-shimosanzai Saito-shi, Miyazaki
TEL 0983-44-5221
Email matuu3hp@iwk.bbiq.jp

Public contact
Name of contact person
1st name Keishi
Middle name
Last name Mori
Organization Shido. Inc.
Division name N/A
Zip code 140-0001
Address 1-9-7-1015, Kitashinagawa, Shinagawa-ku, Tokyo
TEL 03-4500-5075
Homepage URL
Email info@shido.co.jp

Sponsor
Institute Sanzai Hospital
Institute
Department

Funding Source
Organization Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethics committee at the Diabetes and Lifestyle Center, Tomonaga Clinic
Address Shinyon curumu building 9F, 4-2-23, Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel 03-3351-0032
Email info@tomonaga-clinic.com

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
2021 Year 11 Month 15 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 Enrolling by invitation
Date of protocol fixation
2021 Year 08 Month 24 Day
Date of IRB
2021 Year 10 Month 07 Day
Anticipated trial start date
2021 Year 11 Month 07 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study

Management information
Registered date
2021 Year 11 Month 10 Day
Last modified on
2021 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052514

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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