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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008440
Receipt No. R000009928
Scientific Title Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Date of disclosure of the study information 2012/08/01
Last modified on 2018/01/18

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Basic information
Public title Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Acronym Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Scientific Title Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Scientific Title:Acronym Examination for the effect of combination therapy with raloxifene and eldecalcitol in postmenopausal osteoporotic patients
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Endocrinology and Metabolism Geriatrics Obsterics and gynecology
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the BMD increase at lumbar spine and improve exercise function in postmenopausal osteoporotic patients who had taken combination therapy with raloxifene and eldecalcitol
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of lumbar spine bone mineral density
Key secondary outcomes Change of total hip bone mineral density
Number of fracture occurred
Change of bone metabolic markers
Effect of improve exercise function
Safety

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Raloxifene (60mg/day) + eldecalcidol (0.75 µg/day)
Interventions/Control_2 Raloxifene (60mg/day)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Postmenopausal osteoporotic patients.
Patients who are treated with raloxifene for more than one year.
Patients with informed of consent.
Key exclusion criteria Patients who are diagnosed as contraindication of raloxifene treatments.
Patients who are diagnosed as contraindication of eldecalcitol treatments.
Patients who are inappropriate for this study by physician.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Shiba
Organization Kurume University, Medical Department
Division name Department of Orthopaedic Surgery
Zip code
Address Asahi-machi 67, Kurume city, Fukuoka, 830-0011, Japan
TEL 0942-31-7568
Email nshiba@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroo Matsuse
Organization Kurume University, Medical Department
Division name Department of Orthopaedic Surgery
Zip code
Address Asahi-machi 67, Kurume city, Fukuoka, 830-0011, Japan
TEL 0942-31-7568
Homepage URL
Email matsuse_hiroh@kurume-u.ac.jp

Sponsor
Institute Kurume University, Medical Department
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
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 久留米大学病院(福岡県

Other administrative information
Date of disclosure of the study information
2012 Year 08 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 Open public recruiting
Date of protocol fixation
2012 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 15 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009928


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