UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008035
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email takaima@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi university graduate school of medicine, Department of orthopedic surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009461

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.