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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028508
Receipt No. R000032609
Scientific Title Randomized comparative study on alendronate of different dosage forms in steroid induced osteoporosis
Date of disclosure of the study information 2017/08/03
Last modified on 2017/08/02

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Basic information
Public title Randomized comparative study on alendronate of different dosage forms in steroid induced osteoporosis
Acronym Randomized comparative study on alendronate of different dosage forms in steroid induced osteoporosis
Scientific Title Randomized comparative study on alendronate of different dosage forms in steroid induced osteoporosis
Scientific Title:Acronym Randomized comparative study on alendronate of different dosage forms in steroid induced osteoporosis
Region
Japan

Condition
Condition Steroid induced osteoporosis
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the effectiveness and safety of steroid induced osteoporosis and planned this study to clarify appropriate dosage form in alendronate treatment based on guidelines.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endopoint is the Lumbar spine (L1-L4) bone density change rate 52 weeks after administration.
Key secondary outcomes Secondary endpoints were the rate of change of bone metabolism markers (P1NP and TRACP-5b) during the observation period, morphological vertebral fractures and clinical fractures of the observation period, rate of change of the lumbar TBS after 52 weeks of administration, adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 the Alendronate IV infusion 4 weekly treatment group
Interventions/Control_2 the Alendronate oral weekly treatment group
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who satisfy all the following criteria are targeted.
1) Guidelines for prevention and treatment of steroid osteoporosis Patients meeting the 2014 version (one of the following)
1.Patients with existing vulnerability fractures
2.Patients planning to administer 7.5 mg / day or more in terms of prednisolone
3.Patients over 65 years old
4.Patients with lumbar spine bone density (YAM) less than 70%
5.Patients who are 50 years of age or older, scheduled to be administered at a dose of 5 mg / day or more in terms of prednisolone, patients satisfying any two of YAM of 70 to less than 80%
2) Patients receiving steroid for the first time
3) Patients aged 18 years or older at the time of acquiring consent (regardless of gender)
4) After receiving sufficient explanation for the participation of this clinical study, patients who obtained document consent by the patient's free will with sufficient understanding
Key exclusion criteria Patients who conflict with any of the following will not be included in this clinical study.
1) Patients with a history of hypersensitivity to bisphosphonates
2) Patients with hypocalcemia
3) Patients with disorders delaying esophageal stenosis or esophageal passage such as achalasia
4) Patients who are raising the upper body for more than 30 minutes or who can not stand
5) Patients with AST or ALT more than twice the institution standard value
6) Patients with serum creatinine> 2.0 mg / dL
7) Patients who received osteoporosis treatment drug within 6 months before treatment
8) Patients who participated in other clinical studies (including clinical trials) within 6 months
9) Patients who underwent oral steroid and steroid pulse therapy within 2 years
10) If you do not obtain consent from the substitute
11) Others who judged that the researcher is inappropriate as the subject
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Okada
Organization University of Occupational and Environmental Health, Japan, School of Medicine
Division name The First Department of Internal Medicine
Zip code
Address 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL 093-603-1611
Email y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Torimoto
Organization University of Occupational and Environmental Health, Japan, School of Medicine
Division name The First Department of Internal Medicine
Zip code
Address 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555 Japan
TEL 093-603-1611
Homepage URL
Email torimoto@med.uoeh-u.ac.jp

Sponsor
Institute The First Department of Internal Medicine
University of Occupational and Environmental Health, Japan, School of Medicine
Institute
Department

Funding Source
Organization The First Department of Internal Medicine
University of Occupational and Environmental Health, Japan, School of Medicine
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
2017 Year 08 Month 03 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 02 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032609

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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