UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035515 |
|---|---|
| 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 |
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Basic information
Public title
Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors
Acronym
Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors
Scientific Title
Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors
Scientific Title:Acronym
Efficacy of alfacalcidol and alendronate on lumbar bone mineral density in osteoporotic patients using proton pump inhibitors
Region
| Japan |
Condition
Condition
Patients using Proton pump inhibitors (PPIs)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mass increase effect
Key secondary outcomes
Incidence of fractures
Transition of bone turnover marker
Upper gastrointestinal endoscopy results
Compliance
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
alendronate 35mg per week for one year
Interventions/Control_2
alfacalcidol 1microgram per day for one year
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Osteoporotic patients using proton pump inhibitors
Key exclusion criteria
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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-3 Hongo Bunkyou-ku Tokyo
TEL
03-3813-3111
otaro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Asaoka |
Organization
Juntendo University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3-1-3 Hongo Bunkyou-ku Tokyo
TEL
03-3813-3111
Homepage URL
daisuke@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Hospital
Department of Gastroenterology
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
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
順天堂大学医学部附属順天堂医院(東京都)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/?term=Efficacy+of+alfacalcidol+and+alendronate+on+lumbar+bone+mi
Number of participants that the trial has enrolled
Results
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.
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
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2009 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2019 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040455
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
