UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020711
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mattari20030604@yahoo.co.jp

Sponsor
Institute Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.