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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014570
Receipt No. 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

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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
Last 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
Email amanokoi@saitama-med.ac.jp

Public contact
1st 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
Email takeix@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
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
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
URL(English) https://upload.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


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