UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002551 |
|---|---|
| Receipt number | R000002727 |
| Scientific Title | Prospective examination of clinical efficacy of alendronate which is administrated prophylactically in glucocorticoid-induced osteoporosis |
| Date of disclosure of the study information | 2009/09/27 |
| Last modified on | 2012/07/13 00:11:44 |
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Basic information
Public title
Prospective examination of clinical efficacy of alendronate which is administrated prophylactically in glucocorticoid-induced osteoporosis
Acronym
HASEB(Hyogo Association of Secondary Endocrine and Bone metabolism)Study 3
Scientific Title
Prospective examination of clinical efficacy of alendronate which is administrated prophylactically in glucocorticoid-induced osteoporosis
Scientific Title:Acronym
HASEB(Hyogo Association of Secondary Endocrine and Bone metabolism)Study 3
Region
| Japan |
Condition
Condition
glucocorticoid-induced osteoporosis
Classification by specialty
| Medicine in general | Pneumology | Endocrinology and Metabolism |
| Neurology | Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of alendronate which is administrated prophylactically during the early stage of glucocorticoid therapy, the present study is performed to analyze biochemical markers of bone metabolism, bone mineral density and indices of glucose and lipid metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The serum levels of BAP, OC, TRAP-5b and urinary levels of NTx are measured on days 0, 7 and at 1, 3, 6, 12 months after glucocorticoid treatment. Bone mineral density values are measured at the lumbar spine on day 0 and at 1, 3, 6, 12 months after glucocorticoid therapy. In all subjects, conventional thoracic and spinal radiographs in lateral and antero-posterior projections are obtained on day 0 and at 1 year after glucocorticoid therapy.
Key secondary outcomes
The serum levels of total cholesterol, HDL cholesterol, triglycerides, glucose, insulin are measured on days 0, 7 and at 1, 3, 6, 12 months after glucocorticoid treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The alendronate 35mg is administered before the glucocorticoid is administered to all cases. Afterwards, 5mg/day or 35mg/week of alendronate is additionally administered to the glucocorticoid administering beginning. The period is one year. The use medicine is alendronate.
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The dosage of theglucocorticoid by prednisolone (PSL) conversion 20mg/day or more is a patient to whom administering for three months or more is scheduled. Or, the patient increased from a past amount of the glucocorticoid use to administering for three months or more by 20mg/day or more. Patient who received agreement of this research participation from person in question.
Key exclusion criteria
1)Woman who hopes for pregnancy
2)Patient who has serious hepatopathy, renal damage, and cardiac disease
3)Patient who has received administering medicine that influences bone metabolism Medicine made of patient protein assimilation steroid(Winstrol, Primobolan, and Miotoron, etc.), Calcitonin(Elcitonin, Calcitriol, and Salmotonin, etc.), Ipriflavone(osten), vitamin K2(Glakey), androgenic hormone (TESTINON etc.), and female hormone (PREMARIN etc.), Raloxifene(Evista). However, after taking the medicine is stopped for eight weeks, it is possible to register.
Patient who has received administering bisphosphonate. However, after taking the bisphosphonate is stopped for six months, it is possible to register.
4)Patient who judged it is improper to participation of physician in charge in clinical trial.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mika Yamauchi |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
Address
89-1, Enya-cho, Izumo-city, Shimane, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Internal Medicine 1
Zip code
Address
TEL
0853-20-2183
Homepage URL
yamauchi@med.shimane-u.ac.jp
Sponsor or person
Institute
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
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
| 2009 | Year | 09 | Month | 27 | 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
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 26 | Day |
Last modified on
| 2012 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002727
