UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033285 |
|---|---|
| Receipt number | R000037922 |
| Scientific Title | The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial |
| Date of disclosure of the study information | 2018/07/05 |
| Last modified on | 2019/07/06 22:18:43 |
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Basic information
Public title
The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial
Acronym
The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease
Scientific Title
The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial
Scientific Title:Acronym
The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the improvement of bone mineral density (BMD) for 2 years for 2 years between oran and intravenous medicaments in patients with Parkinson's diseaase who administered bisphosphonate agent. Moreover, the preventive effect for new fragile fracture or correlation bewtween spinal alignment and quality of life of these agents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary evaluation item:
change of the mean BMD in the prximal femur 2 years after initial treatment
secondary evaluation item:
1.Change of the mean BMD in the proximal femur or lumbar spine 2 years after initial tramentt
2.Change of the bone absorption marker
3.Prevalence of new-onset fragile fracture
4.Correlation between QOL and spinal alignment
5.Longitudinal evaluation of BMD or bone resorption marker
Safty assessment:
Incidecne of adverse reactions for follow-up period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral bisphosphonate agent group: taking orally Minodronic Acid Hydrate (50mg) 1 tablet per 4 weeks
Interventions/Control_2
Intravenous bisphosphonate agent group: injecting Zoledronic Acid (5mg) 1 ampule per 48 weeks
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
1.50 years or more of age at the time of the consent
2.Patient with Parkinson's disease diagnosed by a professional neurologist
3.patient with primary osteoporosis as in the following case;
･histroy of any types of fragile fracture
･<80% of young adult mean in dual-energy x-ray absorptiometry
4.untreated patient with bone antiresorptive agent or bone anabolic agent
5.patient obtaining the consent based on the patient's free will
6.patient taking anti-Parkinson's disease agent without dysphasia
Key exclusion criteria
1.patient corresponding to contraindication based on the attached document of the bone antiresorptive agents
2.patient with Hoen-Yahr grade 5 Parkinson's disease
3.patient who is considered not to be suited for this survey
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Orthopaedic Surgery
Zip code
951-8510
Address
1-757 Asahimachidori, Chuoku, Niigata City
TEL
025-227-2272
keiwatanabe_39jp@live.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Orthopaedic Surgery
Zip code
951-8510
Address
1-757 Asahimachidori, Chuoku, Niigata City
TEL
025-227-2272
Homepage URL
keiwatanabe_39jp@live.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Neurology, Nishi-Niigata Chuo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethics committee of the Niigata University Graduate School of Medical and Dental Sciences
Address
1-757 Asahimachidori, Chuoku, Niigata City, JAPAN
Tel
025-227-2625
ethics@adm.niigata-u.ac.jp
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
新潟大学医歯学総合病院(新潟市)、西新潟中央病院(新潟市)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
https://niigata.bvits.com/rinri/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.niigata-u.ac.jp/ort/
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037922
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
