UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042547 |
|---|---|
| Receipt number | R000048560 |
| Scientific Title | The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics. |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2021/05/10 10:43:50 |
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Basic information
Public title
The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Acronym
The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Scientific Title
The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Scientific Title:Acronym
The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Region
| Japan |
Condition
Condition
Primary osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety and the influence of patient characteristics of treatment with zoledronic acid.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of change in the lumbar spine BMD.
Key secondary outcomes
The rate of change in the femoral neck BMD, the changes in type I procollagen N-terminal propeptide (P1NP), tartrate-resistant acid phosphatase-5b (TRACP-5b), VAS score of back pain, Japanese Osteoporosis Quality of Life Questionnaire (JOQOL).
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who met the required inclusion criteria were enrolled in this study.
1. Patients with osteoporosis starting the treatment using ZOL from November 2016 to June 2019 at Koenji Orthopedics Clinic
2. Patients 55 years of age or older
3. Postmenopausal women who were diagnosed with primary osteoporosis
Key exclusion criteria
1. Patients with a metabolic bone disease other than osteoporosis
2. Patients with a history of hypersensitivity to the study drug or BP
3. Patients who have severe renal impairment (creatinine clearance < 35 mL/min) at the start
4. Patients who are dehydrated (high fever, severe diarrhea and vomiting, etc.) at the start
5. Patients who have hypocalcemia at the start
6. Patients whom the physicians judged to be unsuitable because of idiosyncratic complications and markedly different background
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Omura |
Organization
Koenji Orthopedics Clinic
Division name
N/A
Zip code
166-0003
Address
4-29-2 Koenji-minami, Suginami-ku, Tokyo, Japan.
TEL
03-5377-3291
oomura-f@rg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Omura |
Organization
Koenji Orthopedics Clinic
Division name
N/A
Zip code
166-0003
Address
4-29-2 Koenji-minami, Suginami-ku, Tokyo, Japan.
TEL
03-5377-3291
Homepage URL
oomura-f@rg7.so-net.ne.jp
Sponsor or person
Institute
Koenji Orthopedics Clinic
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
Japan Medical Association Ethical Review Board
Address
2-28-8 Honkomagome, Bunkyo-ku, Tokyo,Japan
Tel
03-5319-3781
rinri@jmacct.med.or.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
高円寺整形外科（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ecronicon.com/ecor/ECOR-12-00747.php
Number of participants that the trial has enrolled
88
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 06 | Month | 09 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 14 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048560
