UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011846 |
|---|---|
| Receipt number | R000013846 |
| Scientific Title | Efficacy of minodronic acid hydrate in patients with osteoporosis |
| Date of disclosure of the study information | 2013/09/25 |
| Last modified on | 2018/03/08 19:07:11 |
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Basic information
Public title
Efficacy of minodronic acid hydrate in patients with osteoporosis
Acronym
Efficacy of minodronic acid hydrate in patients with osteoporosis
Scientific Title
Efficacy of minodronic acid hydrate in patients with osteoporosis
Scientific Title:Acronym
Efficacy of minodronic acid hydrate in patients with osteoporosis
Region
| Japan |
Condition
Condition
osteoporosis
Classification by specialty
| Obstetrics and Gynecology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of y minodronic acid hydrate (MIN) in both naive and other bisphosphonates-treatment resistant osteoporotic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Newly diagnosed Osteoporotic patients
-Changes in bone metabolic markers
-Changes in QOL score(SF-8)
(2) Other bisphosphonates-treatment resistant osteoporotic patients.
-Changes in bone mineral density
-Changes in hip structure analysis
Key secondary outcomes
(1)Newly diagnosed Osteoporotic patients
-Correlation between bone metabolic markers
-Correlation between the number of incident fracture and the efficacy of MIN
-Incidence of new vertebral fracture
-Adherence to MIN
- Incidence of side effects
(2) Other bisphosphonates-treatment resistant osteoporotic patients.
-Changes in bone metabolic markers
-Correlation between bone metabolic markers and bone mineral density
-Correlation between the number of incident fracture and the efficacy of MIN
-Incidence of new vertebral fracture
-Adherence to MIN
- Incidence of side effects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients included are to be given minodronic acid hydrate
Interventions/Control_2
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 take bisphosphonates more than 2 years and do not gain the bone mineral density (lumbar vertebra or hip) over 3 % since prescription of bisphosphonates
3)Age-lower limit: 50 years old, age-higher limit: none
4)Patients able to walk themselves
5)Patients giving informed consent
Key exclusion criteria
1)Secondary osteoporotic patient
2)Patients with peptic ulcers
3)Patients with history of gastrectomy or broad gastrointestinal resection 4)Patients who diagnosed malignancy
4)Patients with obstacles which delays esophagus passage of stricture of the esophagus or achalasia
5) Patients who have raised the upper part of the body for 30 minutes or it cannot be standing
6) Patients with hypersensitivity to bisphosphonates
7)Patients with receiving therapy of SERM or bisphosphonates
8)Patients with receiving therapy of drugs affecting bone metabolism within 8 weeks before study
9)Patients with hypocalcemia
10)Patients with severe hepatic and renal dusfunction and cardiovascular disease
11)Patients with pregnancy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hagino |
Organization
Tottori University
Division name
Faculty of Medicine, School of Health Science
Zip code
Address
86 Nishimachi, Yonago-shi, Tottori, Japan
TEL
0859-38-6308
hagino@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hagino |
Organization
Tottori University
Division name
School of Health Science, Faculty of Medicine
Zip code
Address
86 Nishimachi, Yonago-shi, Tottori, Japan
TEL
0859-38-6308
Homepage URL
hagino@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University, Faculty of Medicine, School of Health Science
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013846
