UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety analysis of monthly minodronic acid in Japanese osteoporotic patients switched from traditional bisphosphonates
Title of the study (Brief title)	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 Obsterics 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	Satoshi Ikeda
Organization	Ken-Ai Memorial Hospital
Division name	Department of Orthopedic Surgery
Address	1191 Oaza Kimori, Onga-Machi, Onga-Gun Fukuoka, 811-4313 Japan
TEL	093-293-7090
Email

Public contact
Name of contact person
Organization	Ken-Ai Memorial Hospital
Division name	Department of Orthopedic Surgery
Address
TEL
Homepage URL
Email	s-ikeda@med.uoeh-u.ac.jp

Sponsor
Institute	Ken-Ai Memorial Hospital
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	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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011233