UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014570 |
|---|---|
| Receipt number | R000016947 |
| Scientific Title | Comparison of usefulness between denosumab and alendronate after teriparatide therapy in patients with glucocorticoid-induced osteoporosis (GIOP) |
| Date of disclosure of the study information | 2014/07/16 |
| Last modified on | 2018/08/09 14:23:47 |
* 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
Comparison of usefulness between denosumab and alendronate after teriparatide therapy in patients with glucocorticoid-induced osteoporosis (GIOP)
Acronym
Denosumab or alendronate after teriparatide in GIOP patients
Scientific Title
Comparison of usefulness between denosumab and alendronate after teriparatide therapy in patients with glucocorticoid-induced osteoporosis (GIOP)
Scientific Title:Acronym
Denosumab or alendronate after teriparatide in GIOP patients
Region
| Japan |
Condition
Condition
glucocorticoid-induced osteoporosis (GIOP)
Classification by specialty
| Medicine in general | Clinical immunology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of usefulness between denosumab and alendronates for the prevention of symptomatic vertebral fracture in elderly GIOP patients (more than 65 years old) with collagen vascular diseases who have done teriparatide therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at any time during 3 years of this study.
Key secondary outcomes
Non symptomatic vertebral fractures and non-vertebral fractures deetermined by plain X-ray.
Bone mineral density values, those are measured at the lumbar spine.
The serum levels of NTX, osteocalcin, 25(OH)vitamin D, etc.
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
YES
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Denosumab
Interventions/Control_2
alendronate
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with GIOP who have done full teriparatide therapy
Key exclusion criteria
1)Patients who have serious renal disorder (eGFR<35ml/min or Cr>1.5mg/ml)
2)Patient who has a history of renal stone past 5 years
3)Patients with primary or secondary hyperparathyroidism
4)Patients with hyperthyroidism or hypothyroidism
5)Patients who are considered to be contraindicated for bisphosphonates or denosumab
6)Patients who are treated with warfarin or digitalis
7)Patients who have newly received drugs having influence on bone remodeling within 6 months at inclusion of the study (estriol, estradiol, Vitamin D3, Vitamin K2, SERM(Raloxifene, bazedoxifene), Calcitonin, Ipriflavone, Steroids)
8)Patients who had received bisphosphonates during teriparatide therapy
9) Patients who are thought to be inappropriate for this study by physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Amano |
Organization
Saitama Medical Center,
Saitama Medical University
Division name
Department of Rheumatology and Clinical Immunology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL
0492283859
amanokoi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Takei |
Organization
Saitama Medical Center, Saitama Medical Universitity
Division name
Department of Rheumatology & Clinical Immunology
Zip code
Address
1981 Kamoda Kawagoe, Saitama 350-8550
TEL
0492283574
Homepage URL
takeix@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center,
Saitama Medical University
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
| 2014 | Year | 07 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 16 | Day |
Last modified on
| 2018 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016947
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
