UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008035 |
|---|---|
| Receipt number | R000009461 |
| Scientific Title | Comparison of monthly minodronate versus weekly bisphosphonate on bone mineral density in women with postmenopausal osteoporosis |
| Date of disclosure of the study information | 2012/05/28 |
| Last modified on | 2016/11/29 14:47:28 |
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Basic information
Public title
Comparison of monthly minodronate versus weekly bisphosphonate on bone mineral density in women with postmenopausal osteoporosis
Acronym
Comparison of monthly minodronate versus weekly bisphosphonate on bone mineral density in women with postmenopausal osteoporosis
Scientific Title
Comparison of monthly minodronate versus weekly bisphosphonate on bone mineral density in women with postmenopausal osteoporosis
Scientific Title:Acronym
Comparison of monthly minodronate versus weekly bisphosphonate on bone mineral density in women with postmenopausal osteoporosis
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bone mineral density and bone turnover marker are evaluated for once-monthly (4-weekly) versus once-weekly bisphosphonate in women with postmenopausal osteoporosis.
This is a 24-week prospective, randomized, open-label, multicenter trial with a two-period and two-sequence crossover treatment design.
Further, patient preferences, quality of life and VAS are assessed for both regimens.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change L2-4 BMD using DXA and bone turnover maker (TRACP-5b) are analyzed separately for baseline to 24-week and 48-week.
Key secondary outcomes
QOL and VAS are measured at baseline , 24-week and 48-week after treatment. Patient preference is assessed at 48 weeks after treatment.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Test drug (24 weeks),Control drug (24 weeks)
[Test drug (once 4-weekly BP)]
Minodronic acid hydrate
(Recalbon or Bonoteo tablets) 50mg
[Control drug (once-weekly BP)]
Alendronate tablets 35mg or risedronate tablets 17.5mg
Interventions/Control_2
Control drug (24 weeks),Test drug (24 weeks)
[Control drug (once-weekly BP)]
Alendronate tablets 35mg or risedronate tablets 17.5mg
[Test drug (once 4-weekly BP)]
Minodronic acid hydrate
(Recalbon or Bonoteo tablets) 50mg
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
Female
Key inclusion criteria
1)Primary osteoporotic patients
2)Patients who did not take bisphosphonate more than 6 months before this trial
3)Age-lower limit: 50 years old, age-higher limit: none
4)Patients who passed after the menopause for two years or more before informed consent
5)Hospitalization/outpatient: no object
Key exclusion criteria
1)Secondary osteoporotic patient and patients who had disorders such as other causes of low bone mineral density
2)Patients who had history of gastrectomy or broad gastrointestinal resection
3)Patients who diagnosed malignancy
4)Patients who had history of radiation to lumber or pelvic section
5)Patients who had an observation affecting bone mineral density using DXA
6)Patients who received therapy of IV bisphosphonate
7)Patients who received therapy of strontium or parathyroid hormone
8)Patients who took calcitonin within a month before this trial
9)Patients who is receiving therapy of oral steroid
10)Patients who is receiving therapy of biologics or DMARDs
11)Patients who have obstacles which delays esophagus passage of stricture of the esophagus or achalasia
12)Patients who have raised the upper part of the body for 30 minutes or it cannot be standing
13)Patients who have serum calcium levels 10.6 or more mg/L
14)Patients who have serum calcium levels 8.0 or less mg/L
15)Patients who have severe renal dysfunction (creatinine clearance levels below 30 mL/min)
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Imagama |
Organization
Yamaguchi university graduate school of medicine
Division name
Orthopedic Surgery
Zip code
Address
1-1-1 minami-kogushi, ube, yamaguchi, Japan
TEL
0836-22-2266
takaima@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Imagama |
Organization
Yamaguchi university graduate school of medicine
Division name
Orthopedic Surgery
Zip code
Address
1-1-1 minami-kogushi, ube, yamaguchi, Japan
TEL
0836-22-2266
Homepage URL
takaima@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi university graduate school of medicine, Department of orthopedic surgery
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
ONO PHARMACEUTICAL CO., LTD.
Name of secondary funder(s)
None
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
山口大学医学部附属病院（山口県）、山口労災病院（山口県）、周南記念病院（山口県）、関門医療センター（山口県）、山口県立総合医療センター（山口県）、徳山中央病院（山口県）、新南陽市民病院（山口県）、山陽小野田市民病院（山口県）、周東総合病院（山口県）、宇部記念病院（山口県）、長門総合病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 27 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009461
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