UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046026 |
|---|---|
| Receipt number | R000052514 |
| Scientific Title | TWICE-Follow up study |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2026/03/03 11:23:15 |
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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
matuu3hp@iwk.bbiq.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mori |
Organization
Shido. Inc.
Division name
N/A
Zip code
140-0001
Address
614,3-13-2, Kameari, Katsushika-ku, Tokyo
TEL
03-4500-5075
Homepage URL
info@shido.co.jp
Sponsor or person
Institute
Sanzai Hospital
Institute
Department
Personal name
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
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
https://doi.org/10.1007/s00774-026-01690-7
Number of participants that the trial has enrolled
54
Results
In the 1/W-TPTD (BP/denosumab) group, a significant increase in L2-4 BMD was observed. In the 2/W-TPTD (BP/denosumab) group, a significant increase in total hip, neck, and L2-4BMD values was observed. Analysis by 3D-SHAPER revealed that both the 1/W-TPTD (BP/denosumab) and 2/W-TPTD (BP/denosumab) groups demonstrated significant increases incortical sBMD and vBMD 2 years after the initiation of post-treatment.
Results date posted
| 2026 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1/W-TPTD (BP/ Denosumab) Group n: 20 Age (years): 73.4 +/- 6.0 Body Mass Index (kg/m2): 23.5 +/- 3.7 25-OHvitaminD3 (ng/mL): 27.6 +/- 8.4 Estimated GFR (mL/min/1.73m2): 68.6 +/-14 Sex (Male): 1 (5%), (Female): 19 (95%)
1/W-TPTD (Others) Group n: 7 Age (years): 77.9 +/- 1.9 Body Mass Index (kg/m2): 23.6 +/- 1.7 25-OHvitaminD3 (ng/mL): 25.6 +/- 1.6 Estimated GFR (mL/min/1.73m2): 65.6 +/- 5.2 Sex(Male): 0 (0%), (Female): 7 (100%)
2/W-TPTD (BP/ Denosumab) Group n: 22 Age (years): 75.5 +/- 1.2 Body Mass Index (kg/m2): 21.9 +/- 0.8 25-OHvitaminD3 (ng/mL): 24.2 +/- 1.1 Estimated GFR (mL/min/1.73m2): 62.7 +/-3.1 Sex (Male): 4 (18.2%), (Female): 18 (81.8%)
2/W-TPTD (Others) Group n: 5 Age (years): 75.0 +/- 2.3 Body Mass Index (kg/m2): 23.9 +/- 1.9 25-OHvitaminD3 (ng/mL): 26.2 +/- 4.3 Estimated GFR (mL/min/1.73m2): 64.8 +/- 7.6 Sex(Male): 0 (0%), (Female): 5 (100%)
Participant flow
Follow-up data after the clinical trial could be collected from 27 subjects in the 1/W-TPTD group and 27 in the group 2/W-TPTD. Among those subjects, 20 in the 1/W-TPTD(BP/denosumab) group, 7 in the 1/W-TPTD (others) group, 22 in the 2/W-TPTD (BP/denosumab) group, and 5 in the group 2/W-TPTD (others) were included in the analysis of changes inthe BMD by post-treatment. In the 1/W-TPTD group, three patients dropped out between 1 and 2 years, and two patients were not evaluated due to treatment changes. In the 2/W-TPTDgroup, five patients dropped out between 1 and 2 years.
Adverse events
N/A
Outcome measures
In the 1/W-TPTD (BP/denosumab) group, a significant increase in L2-4 BMD was observed. In the 2/W-TPTD (BP/denosumab) group, a significant increase in total hip, neck, and L2-4BMD values was observed. Analysis by 3D-SHAPER revealed that both the 1/W-TPTD (BP/denosumab) and 2/W-TPTD (BP/denosumab) groups demonstrated significant increases incortical sBMD and vBMD 2 years after the initiation of post-treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2021 | Year | 11 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052514
