UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates
Title of the study (Brief title)	Efficacy of monthly minodronate for osteoporosis in RA
Region	Japan

Condition
Condition	Osteoporosis
Classification by specialty	Medicine in general Endocrinology and Metabolism Clinical immunology Obsterics and gynecology Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness of minodronate in osteoporotic patients, and to compare with those of traditional bisphosphonates
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	(1) Changes in bone mineral density (2) Changes TRACP-5b, CTX, P1NP, BAP, uDPD, ucOC, MMP-3, CRP, 1,25(OH)2VtD, serumCa, and serumP
Key secondary outcomes	(1) MHAQ (2) mini-JOQOL (3) Patient Satisfaction Questionnaire (4) Treatment adherence (5) Side effects (6) Incident fracture

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	Minodronic acid (50mg/month or 1mg/day)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. RA patients with osteoporosis taking BPs for at least three months 2. Patients with RA for at least six months
Key exclusion criteria	1. Patients who underwent rheumatoid arthritis surgery less than three months before entry 2. Patients experienced any fracture less than three months before surgery 3. Patients with active RA and inadequate response to treatment 4. Patients with peptic ulcers 5. Patients with esophageal stricture or achalasia 6. Patients unable to remain upright for 30 min after dosing 7. Patients with hypocalcaemia 8. Females with pregnancy and lactating
Target sample size	100

Research contact person
Name of lead principal investigator	Kenrin Shi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address	2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
Email

Public contact
Name of contact person	Kenrin Shi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Orthopaedic Surgery
Address
TEL	06-6879-3552
Homepage URL
Email

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

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)

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 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 11 Day
Anticipated trial start date	2012 Year 04 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 01 Day
Last modified on	2018 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012981