UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015180 |
|---|---|
| Receipt number | R000017630 |
| Scientific Title | The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2021/03/23 09:44:58 |
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Basic information
Public title
The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Acronym
The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Scientific Title
The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Scientific Title:Acronym
The clinical study of the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis
Region
| Japan |
Condition
Condition
Glucocorticoid-induced osteoporosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to assess the safety and efficacy of denosumab for glucocorticoid-induced osteoporosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of bone mineral density after 6 months, 12 months, 18 months,and 24 months
Key secondary outcomes
The change of bone metabolism marker (BAP and TRACP-5b) after 3 months, 6 months, 12 months, 18 months,and 24 months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SC denosumab 60mg every 6 months for 2 years
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.Patients who took gulcocorticoid (the gulcocorticoid dose was not less than 1mg/day and not more than 10mg/day prednisone or equivalent last 6 months) for over 12 months
2.Patients who took bisphosphonate or teriparatide or activated vitamin D for over 12 months
3.Patients who didn't improvement in bone mineral density compared with 6 months ago
4.Patients who scored >3 in the literature "Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and Mineral Research"
Key exclusion criteria
Patients with hypocalcemia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shuzo |
| Middle name | |
| Last name | Yoshida |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
569-886
Address
Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
TEL
+81-72-683-1221
in1307@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | ishida |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
659-8686
Address
Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
TEL
+81-72-683-1221
Homepage URL
in1342@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
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
Osaka Medical College
Address
Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
Tel
072-683-1221
rinri@osaka-med.ac.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
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33624165/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33624165/
Number of participants that the trial has enrolled
56
Results
Denosumab significantly increased the mean BMD of the lumbar spine and bilateral hip (5.8%, and 1.3%, respectively).
Results date posted
| 2021 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All patients fulfilled the following inclusion criteria: 1) more than 20
years old; 2) received prednisolone (PSL) of more than 1 mg/day for 12 months; 3) prior treatment of osteoporosis
for more than 12 months (bisphosphonates, rhPTH, or active vitamin D 3 ); 4) no increase in T-score at lumbar spine
or total hip compared to more than 6 months ago; 5) score more than 3 for risk factors based on the Japanese Society for
Bone and Mineral Research guideline for GIOP (prior fracture, age, GC dose, and BMD)
Participant flow
Patients with rheumatic diseases were recruited from Osaka Medical College hospital during the
period from March 2015 to February 2017.
Adverse events
Fragility fractures occurred in three patients during the study period.
Outcome measures
Denosumab significantly increased the mean BMD of the lumbar spine and bilateral hip (5.8%, and 1.3%, respectively).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017630
