UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020711 |
|---|---|
| Receipt number | R000023846 |
| Scientific Title | Efficacy and safety of denosmab in patients with glucocorticoid-induced osteoporosis refractory to combination therapy with bisphosphonate and vitamin D |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2020/03/12 11:01:10 |
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Basic information
Public title
Efficacy and safety of denosmab in patients with glucocorticoid-induced osteoporosis refractory to combination therapy with bisphosphonate and vitamin D
Acronym
Denosmab in treatment-refractory glucocorticoid-induced osteoporosis
Scientific Title
Efficacy and safety of denosmab in patients with glucocorticoid-induced osteoporosis refractory to combination therapy with bisphosphonate and vitamin D
Scientific Title:Acronym
Denosmab in treatment-refractory glucocorticoid-induced osteoporosis
Region
| Japan |
Condition
Condition
Glucocorticoid-induced osteoporosis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy of switching from bisphosphonate to denosumab in patients with glucocorticoid-induced osteoporosis refractory to the combination therapy with bisphosphonate and vitamin D.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of bone mineral density of lumbar spine and femoral neck from baseline to 12 months.
Key secondary outcomes
Changes of bone markers from baseline to 12 months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Denosumab group (Denosmab 60mg/month and vitamin D)
Interventions/Control_2
Bisphosphonate group (bisphosphonate and vitamin D)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In adult (>= 20-year-old) patients with systemic rheumatic diseases, such as rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, Sjogren's syndrome, mixed connective tissue disease, systemic vasculitides, Behcet's disease, polymyalgia rheumatica, receiving systemic glucocorticoids at the averaged dose of 2.5 mg prednisolone equivalent daily or more and in whom treatment for glucocorticoid-induced osteoporosis was recommended according to the guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and Mineral Research, patients who developed new fragility fractures; or whose bone mineral density values in lumbar spine or femoral neck was below 80% of young adult mean (YAM) and had not increased by 2% over 12 months during treatment with an oral bisphosphonate and a vitamin D analogue for 12 months; or whose bone mineral density values in lumbar spine or femoral neck was below 70% of YAM or was equal to or below -2.5 by T-score were included in this study.
Key exclusion criteria
Persons who had allergy to ingredients of denosmab injection, hypocalcemia, plan for invasive dental therapy, such as dental extraction, previous or current use of denosmab or teriparatide, and renal dysfunction with estimated glomerular filtration rate below 30% were excluded. Pregnant and breastfeeding women, woman who have plan for pregnancy, and persons judged as ineligible for this study by attending physician were also excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taio Naniwa |
Organization
Nagoya City University Hospital
Division name
Division of Respiratory Medicine, Allergy and Rheumatology
Zip code
Address
Kawasumi, Mizuho-ku, Nagoya, Aichi, Japan.
TEL
052-851-5511
tnaniwa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin-ichiro Ohmura |
Organization
Nagoya City University Hospital
Division name
Division of Respiratory Medicine, Allergy and Rheumatology
Zip code
Address
Kawasumi, Mizuho-ku, Nagoya, Aichi, Japan.
TEL
052-851-5511
Homepage URL
mattari20030604@yahoo.co.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences
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
Address
Tel
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
| 2016 | Year | 01 | Month | 31 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 23 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023846
