UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037148 |
|---|---|
| Receipt number | R000042330 |
| Scientific Title | Clinical research on the effect of changing from denosumab to zoledronic acid (Multicenter collaborative retrospective observational research) |
| Date of disclosure of the study information | 2019/06/28 |
| Last modified on | 2020/12/24 14:43:11 |
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Basic information
Public title
Clinical research on the effect of changing from denosumab to zoledronic acid
(Multicenter collaborative retrospective observational research)
Acronym
SM201901
Scientific Title
Clinical research on the effect of changing from denosumab to zoledronic acid
(Multicenter collaborative retrospective observational research)
Scientific Title:Acronym
SM201901
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyze bone mineral density, transition of bone metabolism markers and new fracture occurrence status in patients who changed osteoporosis treatment drug from denosumab (Dmab) to zoledronic acid (ZOL).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density (Lumbar spine, Proximal femur total, Femoral neck)
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Being a patient diagnosed with osteoporosis
(2) Patients who are judged to be the most suitable Dmab for the treatment of osteoporosis
(3) Being patient who can expect survival more than six months after administration of Dmab
(4) Patients who are 20 years of age or older at the Dmab start date
(5) Patients whose treatment after administration of Dmab is ZOL
Key exclusion criteria
(1) Patients undergoing treatment for malignancy
(2) Patients with severe heart disease and cerebrovascular disease
(3) Patients with serious diseases such as pancreas and blood
(4) Patients with severe renal dysfunction or failure (for example, patients with eGFR (estimated glomerular filtration rate) less than 3.0 mL /min/1.73 m2, patients on dialysis)
(5) In addition, patients that the research investigator or the doctor judged inappropriate for the target
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Yoshioka |
Organization
Shimura Hospital
Division name
Orthopedics Department
Zip code
730-0841
Address
3-13, Funairimachi, Nakaku, Hiroshima
TEL
082-294-5151
t-yossy@rc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Yoshioka |
Organization
Shimura Hospital
Division name
Orthopedics Department
Zip code
730-0841
Address
3-13, Funairimachi, Nakaku, Hiroshima
TEL
082-294-5151
Homepage URL
t-yossy@rc4.so-net.ne.jp
Sponsor or person
Institute
Orthopedics Department, Shimura Hospital
Institute
Department
Personal name
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
Nihonbashi Sakura Clinic
Address
1-9-2, nihonbashi kayabacho, chuoku, Tokyo
Tel
03-6661-9061
k-hosoya@ouryokukai.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 | 06 | Month | 28 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32656645/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32656645/
Number of participants that the trial has enrolled
30
Results
Neither clinical vertebral fractures nor X-ray morphological new vertebral fractures occurred in 30 patients evaluated for fractures at 6 months and 12 months after ZOL administration.
Results date posted
| 2020 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/32656645/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/32656645/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/32656645/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/32656645/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Denosumab (hereinafter: Dmab) is a useful drug that increases bone density over time and reduces fracture risk in the treatment of osteoporosis. However, it is known that the discontinuation of administration causes rebound such as overshoot of bone metabolism markers, sharp decrease of bone density, and occurrence of multiple vertebral fracture.
As a precautionary measure, it is described as a precaution in the package insert of Dmab to consider the use of bone resorption suppressant when interrupting Dmab. However, it does not describe the specific medicine or the timing of switching.
Therefore, the influence of switching from Dmab to zoledronic acid (hereinafter referred to as ZOL) is examined. In addition, this research will be conducted in accordance with "Ethical guidelines on medical research for human subjects" (December 22, 2014, partially revised on February 28, 2017).
Management information
Registered date
| 2019 | Year | 06 | Month | 24 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042330
