Unique ID issued by UMIN | UMIN000013916 |
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Receipt number | 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 21:32:48 |
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
Effect of monthly minodronate for the treatment of osteoporosis in women with gynecologic malignancies after switching from raloxifene hydrochloride
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
Effect of monthly minodronate for the treatment of osteoporosis in women with gynecologic malignancies after switching from raloxifene hydrochloride
Japan |
Osteoporosis
Endocrinology and Metabolism | Obstetrics and Gynecology | Orthopedics |
Malignancy
NO
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
Safety,Efficacy
Hip BMD or lumber BMD
Bone turnover markers (serum type I collagen cross-linked N-telopeptide)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Minodronate
20 | years-old | <= |
Not applicable |
Female
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
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
50
1st name | |
Middle name | |
Last name | Tadashi Kimura |
Osaka University Graduate School of Medicine
Department of Obstetrics and Gynecology
2-2 Yamadaoka, Suita, Osaka 565- 0879
06-6879-3351
tadashi@gyne.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Kenjiro Sawada |
Osaka University Graduate School of Medicine
Department of Obstetrics and Gynecology
2-2 Yamadaoka, Suita, Osaka 565- 0879
06-6879-3351
daasawada@gyne.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine
Astellas Pharma Inc.
Profit organization
NO
2014 | Year | 05 | Month | 10 | Day |
Published
Completed
2012 | Year | 06 | Month | 13 | Day |
2012 | Year | 07 | Month | 01 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2017 | Year | 02 | Month | 28 | Day |
2017 | Year | 02 | Month | 28 | Day |
2014 | Year | 05 | Month | 09 | Day |
2018 | Year | 03 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016223
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