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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000987
Receipt No. R000001189
Scientific Title Effects of long-acting alendronate on osteoporosis with impaired glucose metabolism
Date of disclosure of the study information 2008/02/01
Last modified on 2016/03/02

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Basic information
Public title Effects of long-acting alendronate on osteoporosis with impaired glucose metabolism
Acronym Fushimi Bone Study
Scientific Title Effects of long-acting alendronate on osteoporosis with impaired glucose metabolism
Scientific Title:Acronym Fushimi Bone Study
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Medicine in general Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to elucidate the effects of long-acting alendronate on the osteoporosis with and without impaired glucose metabolism
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The first outcome is the effects of long-acting alendronate on the osteoporosis and the second outcome is the comparison of the effects between the patients with and without impaired glucose metabolism
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Outpatients fullfilling the following 1) or 2) and 3) criteria
1)patients in which bone mineral density or femoral neck bone determined by DXA method is less than 70% of the young adult mean (YAM)

2)patients in which bone mineral density or femoral neck bone by DXA method is between 70% and 80%
(1) postmenopausal female
or (2) male patients with at least one of the following risks: excess alcohol drinking (more than 2 units/day), present smoking habit, or family history of femoral neck bone fracture

3)aged between 50 years and 85 years
Key exclusion criteria 1) patient taking bisphosphonates
2) patients contraindicated for alendronate
3) patients under treatment of glucocorticoid or with a history of treatment for 3 years or more.
4) disease states causing secondary osteoporosis: primary hyperparathyroidism, hyperthyroidism, hypogonadism, chronic rheumatic arthritis, multiple myeloma and other hematological diseases,Cushing's syndrome, immobilization, mesotholexate
5) type I diabetes mellitus, diabetes associated with other specific diseases and pregnancy
6) patients not suitable for measuring bone mineral density due to the history of supine bone fracture
7) other various conditions in which the attending doctor decide not suitable for entry.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL 075-641-9161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL 075-641-9161
Homepage URL
Email mnaruse@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization, Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization,Kyoto Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Hospital Organization, Saitama Hospital
Tsuji Clinic
Oishi Clinic
Ogawa Clinic
Kitani Clinic
Taniguchi Clinic
Tsukuda Clinic
Higashimae Clinic
Furukawa Clinic
Furuke Clinic
Wakabayashi Clinic
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
2008 Year 02 Month 01 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
2007 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Type 2 diabetes mellitus is a secondary cause of osteoporosis with high risk for bone fracture and deteriorated QOL. The aim of the study is to investigate the effects of long-acting alendronate on the osteoporosis and to compare the effects between the patients with and without impaired glucose metabolism. Outpatients aged between 50 and 85 years, fullfilling the criteria of the osteoporosis, were enrolled to the study after obtaining written informed consent. Before and after treatment with long-acting alendronate for 6 months, blood and urine tests and determination of BMD were investigated.

Management information
Registered date
2008 Year 01 Month 21 Day
Last modified on
2016 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001189

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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