UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017279 |
|---|---|
| Receipt number | R000020003 |
| Scientific Title | Effect of denosumab for the treatment of postmenoposal osteoporosis in woman caused by the loss of ovarian function due to gynecologic malignancies |
| Date of disclosure of the study information | 2015/04/25 |
| Last modified on | 2019/11/19 17:15:40 |
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Basic information
Public title
Effect of denosumab for the treatment of postmenoposal osteoporosis in woman caused by the loss of ovarian function due to gynecologic malignancies
Acronym
Effect of denosumab for the treatment of osteoporosis in women with gynecologic malignancies
Scientific Title
Effect of denosumab for the treatment of postmenoposal osteoporosis in woman caused by the loss of ovarian function due to gynecologic malignancies
Scientific Title:Acronym
Effect of denosumab for the treatment of osteoporosis in women with gynecologic malignancies
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of denosumab and establish the evidence for the treatment of osteoporosis in women with gynecologic malignancies
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hip BMD and lumber BMD (DXA scan)
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
denosumab
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 diagnosed as being osteoporosis after the treatment of gynecologic malignancies
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 hypersensitivity to denosumab or other bisphosphonates
4. with hypocalcaemia
5. with severe nephropathy
6. with advanced or metastatic malignancy
7. inappropriate to participate in the study
Target sample size
60
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
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
daasawada@gyne.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
| 2015 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2015 | Year | 04 | Month | 25 | Day |
Last modified on
| 2019 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020003
