Unique ID issued by UMIN | UMIN000035515 |
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Receipt number | R000040455 |
Scientific Title | Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors |
Date of disclosure of the study information | 2019/01/18 |
Last modified on | 2019/01/11 11:04:37 |
Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors
Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors
Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors
Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors
Japan |
Patients using Proton pump inhibitors (PPIs)
Gastroenterology |
Others
NO
The aim of the present study was to investigate the efficacy of alendronate on lumbar bone mineral density(BMD) in osteoporotic patients using concomitant PPIs,comparing the effects versus alfacalcidol(AD) in a prospective,randomized,open-label,comparative study.
Safety,Efficacy
Bone mass increase effect
Incidence of fractures
Transition of bone turnover marker
Upper gastrointestinal endoscopy results
Compliance
Safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
alendronate 35mg per week for one year
alfacalcidol 1microgram per day for one year
50 | years-old | <= |
Not applicable |
Male and Female
Osteoporotic patients using proton pump inhibitors
Patients with esophageal transit and delay disorder
Patients can't be instructed to remain upright for >30 min
bisphosphonate allergy
Hypocalcemia
Serious renal disorder or Serum creatinine
>1.5 mg/dL
Severe liver injury
Upper GI endoscopy findings were not analyzed
Doctor judged inappropriate as a subject
100
1st name | |
Middle name | |
Last name | Taro Osada |
Juntendo University Hospital
Department of Gastroenterology
3-1-3 Hongo Bunkyou-ku Tokyo
03-3813-3111
otaro@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Daisuke Asaoka |
Juntendo University Hospital
Department of Gastroenterology
3-1-3 Hongo Bunkyou-ku Tokyo
03-3813-3111
daisuke@juntendo.ac.jp
Juntendo University Hospital
Juntendo University Hospital
Department of Gastroenterology
Self funding
NO
順天堂大学医学部附属順天堂医院(東京都)
2019 | Year | 01 | Month | 18 | Day |
Published
https://www.ncbi.nlm.nih.gov/pubmed/?term=Efficacy+of+alfacalcidol+and+alendronate+on+lumbar+bone+mi
The percentage change in lumbar BMD from baseline to the end of treatment was -0.4% for the AC group vs. 6.8% for the AD group. No significant percentage change of BAP and NTX between the two groups was observed. Subsequent to one year of treatment, the FSSG score did not change from the baseline values for either study group, and no new bone fractures or esophagitis were observed in either group of patients. The findings demonstrated that in osteoporotic patients using concomitant PPIs, there was a greater increase in lumbar BMD after one year of treatment with AD compared with AC.
Completed
2007 | Year | 09 | Month | 04 | Day |
2007 | Year | 10 | Month | 01 | Day |
2009 | Year | 09 | Month | 30 | Day |
2009 | Year | 10 | Month | 01 | Day |
2009 | Year | 10 | Month | 01 | Day |
2010 | Year | 12 | Month | 31 | Day |
2019 | Year | 01 | Month | 11 | Day |
2019 | Year | 01 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040455
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