UMIN-CTR Clinical Trial

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 Obsterics 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
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	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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020003