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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000033285
Date of registration:	05/07/2018
Prospective Registration:	Yes
Primary sponsor:	Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital
Public 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:	The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease: multicenter/ non-blind/ randomised/ exploratory clinical trial - The preventive effect of medicine for osteoporosis on osteopenia in patients with Parkinson's disease
Date of first enrolment:	2018/08/01
Target sample size:	100
Recruitment status:	Pending
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037922
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Kei Watanabe
Address:	1-757 Asahimachidori, Chuoku, Niigata City Japan
Telephone:	025-227-2272
Email:	keiwatanabe_39jp@live.jp
Affiliation:	Niigata University Medical and Dental Hospital Orthopaedic Surgery

Name:	Kei Watanabe
Address:	1-757 Asahimachidori, Chuoku, Niigata City 951-8510 Japan
Telephone:	025-227-2272
Email:	keiwatanabe_39jp@live.jp
Affiliation:	Niigata University Medical and Dental Hospital Orthopaedic Surgery

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 50years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Parkinson's disease

Intervention(s)

Oral bisphosphonate agent group: taking orally Minodronic Acid Hydrate (50mg) 1 tablet per 4 weeks
Intravenous bisphosphonate agent group: injecting Zoledronic Acid (5mg) 1 ampule per 48 weeks

Primary Outcome(s)

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

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Department of Orthopaedic Surgery, Niigata University Medical and Dental Hospital

Secondary Sponsor(s)

Department of Neurology, Nishi-Niigata Chuo Hospital

Ethics review

Status: YES
Approval date:
Contact:

ethics@adm.niigata-u.ac.jp

ethics committee of the Niigata University Graduate School of Medical and Dental Sciences

025-227-2625

ethics@adm.niigata-u.ac.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2021
URL:	http://www.med.niigata-u.ac.jp/ort/

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