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 UMIN000002551
Receipt No. 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

* 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 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
Email

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
Email yamauchi@med.shimane-u.ac.jp

Sponsor
Institute Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.