UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Tadashi Kimura
Organization	Osaka University Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
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	Kenjiro Sawada
Organization	Osaka University Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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