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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013916
Receipt No. R000016223
Scientific Title Effect of monthly minodronate after switching from raloxifene hydrochloride for the treatment of postmenopausal osteoporosis in women with loss of ovarian function due to gynecologic malignancies
Date of disclosure of the study information 2014/05/10
Last modified on 2018/03/08

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Basic information
Public title Effect of monthly minodronate after switching from raloxifene hydrochloride for the treatment of postmenopausal osteoporosis in women with loss of ovarian function due to gynecologic malignancies
Acronym Effect of monthly minodronate for the treatment of osteoporosis in women with gynecologic malignancies after switching from raloxifene hydrochloride
Scientific Title Effect of monthly minodronate after switching from raloxifene hydrochloride for the treatment of postmenopausal osteoporosis in women with loss of ovarian function due to gynecologic malignancies
Scientific Title:Acronym Effect of monthly minodronate for the treatment of osteoporosis in women with gynecologic malignancies after switching from raloxifene hydrochloride
Region
Japan

Condition
Condition Osteoporosis
Classification by specialty
Endocrinology and Metabolism Obsterics and gynecology Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of monthly minodronate for the treatment of osteoporosis in women with gynecologic malignancies after switching from raloxifene hydrochloride due to insufficient responsiveness
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hip BMD or lumber BMD
Bone turnover markers (serum type I collagen cross-linked N-telopeptide)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Minodronate
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

Not applicable
Gender Female
Key inclusion criteria Female patients with osteoporosis associated with gynecologic malignancies, who gained no increase in BMD after being administered with raloxifene hydrochloride for two or more years or more
Key exclusion criteria Patients are excluded if being
1. with concomitant use of other agents for osteoporosis
2. with concomitant use of other agents, which potentially affect bone turnover
3. with esophageal stricture or achalasia
4. unable to remain upright for 30 min after dosing
5. with hypersensitivity to minodronate or other bisphosphonates
6. with hypocalcaemia
7. with aphagia, esophagitis, gastritis, duodenitis, or ulcers
8. with severe nephropathy
9. inappropriate to participate in the study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Kimura
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565- 0879
TEL 06-6879-3351
Email tadashi@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenjiro Sawada
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565- 0879
TEL 06-6879-3351
Homepage URL
Email daasawada@gyne.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 02 Month 28 Day
Date analysis concluded
2017 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 09 Day
Last modified on
2018 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016223

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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