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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035515
Receipt No. 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

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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
Email 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
Email daisuke@juntendo.ac.jp

Sponsor
Institute Juntendo University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040455

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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