UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009575 |
|---|---|
| Receipt number | R000011233 |
| Scientific Title | Efficacy and safety analysis of monthly minodronic acid in Japanese osteoporotic patients switched from traditional bisphosphonates |
| Date of disclosure of the study information | 2012/12/18 |
| Last modified on | 2018/03/08 08:40:24 |
* 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
Efficacy and safety analysis of monthly minodronic acid in Japanese osteoporotic patients switched from traditional bisphosphonates
Acronym
Usefulness of switching to monthly minodronic acid in Japanese osteoporotic patients
Scientific Title
Efficacy and safety analysis of monthly minodronic acid in Japanese osteoporotic patients switched from traditional bisphosphonates
Scientific Title:Acronym
Usefulness of switching to monthly minodronic acid in Japanese osteoporotic patients
Region
| Japan |
Condition
Condition
Osteoporosis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
| Geriatrics | Obstetrics and Gynecology | Orthopedics |
| Radiology | Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of switching to
monthly minodronic acid in Japanese osteoporotic patients who were taking traditional bisphosphonates (BPs). –Six months intervention study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bone mineral density
Bone turnover marker
Key secondary outcomes
Low back pain
Abdominal symptoms
Preference and adherence for BPs
Osteoporotic fracture
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Minodronic acid (50mg/month)
Interventions/Control_2
Another BPs
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with osteoporosis
2. Patients who were taking traditional BPs
3. Patients giving informed consent
Key exclusion criteria
Patients with
1. Esophageal stricture or achalasia
2. Incapability in remaining upright for 30 min
3.Hypersensitivity to minodronic acid and other bisphosphonates
4. Hypocalcemia
5. Pregnancy
6. Aphagia, Esophagitis, Gastritis, Duodenitis or Ulcers
7. Severe renal dysfunction
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ikeda |
Organization
Ken-Ai Memorial Hospital
Division name
Department of Orthopedic Surgery
Zip code
Address
1191 Oaza Kimori, Onga-Machi, Onga-Gun Fukuoka, 811-4313 Japan
TEL
093-293-7090
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ken-Ai Memorial Hospital
Division name
Department of Orthopedic Surgery
Zip code
Address
TEL
Homepage URL
s-ikeda@med.uoeh-u.ac.jp
Sponsor or person
Institute
Ken-Ai Memorial Hospital
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
Sanzai Hospital
Tsurukami Orthopaedic and Rheumatoid Clinic
Kitakyushu General Hospital
Makiyama Chuou Hospital
Obase Hospital
Katsuki Neurosurgery and Orthopaedic Clinic
Name of secondary funder(s)
Teshima Orthopaedic Clinic
Okimoto Clinic
Sakamidorii Hospital
Okamoto Orthopaedic Clinic
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
| 2012 | Year | 12 | Month | 18 | 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
| 2011 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 18 | 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=R000011233
