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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033285
Receipt No. R000037922
Official scientific title of the study 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 2018/07/05

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Basic information
Official scientific title of the study The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial
Title of the study (Brief title) 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 Kei Watanabe
Organization Niigata University Medical and Dental Hospital
Division name Orthopaedic Surgery
Address 1-757 Asahimachidori, Chuoku, Niigata City
TEL 025-227-2272
Email keiwatanabe_39jp@live.jp

Public contact
Name of contact person Kei Watanabe
Organization Niigata University Medical and Dental Hospital
Division name Orthopaedic Surgery
Address 1-757 Asahimachidori, Chuoku, Niigata City
TEL 025-227-2272
Homepage URL
Email keiwatanabe_39jp@live.jp

Sponsor
Institute Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 03 Month 14 Day
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

Related information
URL releasing protocol https://niigata.bvits.com/rinri/
Publication of results Unpublished
URL releasing results http://www.med.niigata-u.ac.jp/ort/
Results
Other related information

Management information
Registered date
2018 Year 07 Month 05 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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