Unique ID issued by UMIN | UMIN000004188 |
---|---|
Receipt number | R000005030 |
Scientific Title | A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias |
Date of disclosure of the study information | 2010/09/10 |
Last modified on | 2014/09/10 12:46:12 |
A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias
Steroid-induced osteoporosis accompanied with interstitial pneumonias
A prospective, randomized controlled trial comparing alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias
Steroid-induced osteoporosis accompanied with interstitial pneumonias
Japan |
interstitial pneumonias
Pneumology |
Others
NO
To evaluate the effects and the safety of alendronate and alendronate plus alphacalcidol therapy in patients with steroid-induced osteoporosis accompanied with interstitial pneumonias
Safety,Efficacy
(1) The change in the lumbar-spine bone mineral density from baseline
(2) The change in the markers of of bone metabolism from baseline
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
Numbered container method
2
Treatment
Medicine |
alendronate
alendronate plus alphacalcidol
20 | years-old | <= |
75 | years-old | >= |
Male and Female
The patients who was expected to treat with oral prednisolone 30mg/day at least for a week and continued with 5mg/day of prednisolone at least for three months for the therapy of interstitial pneumonias
(1) The patients who have severe complications
(2) The patients who have the diseases of bone metabolism
(3) The patients who were administered steroid therapy within a year
(4) The patients who are administered therapy affecting bone metabolism
(5) The patients who have fracture or scoliosis at 3rd to 5th lumbar
(6) The patients who have impaired renal function (Cr > 1.5mg/dl)
(7) The patients who are contraindicated to take alendronate or alphacalcidol
(8) The patients who are pregnant
(9) The patients who attended clinical trials within three months
60
1st name | |
Middle name | |
Last name | Shigeru Kohno |
Nagasaki University School of Medicine
Second Department of Internal Medicine
1-7-1 Sakamoto, Nagasaki, Japan
095-819-7273
nsakamot@nagasaki-u.ac.jp
1st name | |
Middle name | |
Last name | Noriho Sakamoto |
Nagasaki University Hospital
Second Department of Internal Medicine
1-7-1 Sakamoto, Nagasaki, Japan
095-819-7273
nsakamot@nagasaki-u.ac.jp
Nagasaki University School of Medicine
none
Self funding
NO
2010 | Year | 09 | Month | 10 | Day |
Unpublished
No longer recruiting
2008 | Year | 01 | Month | 17 | Day |
2008 | Year | 01 | Month | 01 | Day |
2010 | Year | 09 | Month | 10 | Day |
2014 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005030
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |