UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Drug therapies in older patients with glucocorticoid induced osteoporosis
Title of the study (Brief title)	Drug therapies in older patients with glucocorticoid induced osteoporosis
Region	Japan

Condition
Condition	glucocorticoid induced osteoporosis
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare proportions of vertebral fracture between bisphosphonate monotherapy and combination of bisphosphonate and vitamin D in older (>65y) patients with collagen diseases and glucocorticoid induced osteoporosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	proportions of symptomatic vertebral fracture
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	NO
Dynamic allocation	NO
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	alendronate sodium
Interventions/Control_2	alendronate sodium + activated vitamin D
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age >65y 2. Receiving glucocorticoid for more than 3 months or planed to be received for more than 3 months 3. Starting prednisolone wiht more than 10mg /day
Key exclusion criteria	1. eGFR<35ml/min or Cre<1.5mg/ml 2. Past history of urinary tract stone 3. Hyper- or hypoparathyroidism 4. Hyper- or hypothyroidism 5. Contraindication of alendronate or vitamin D 6. Warfarinization 7. Other conditions that an investigator assess as inappropriate 8.
Target sample size	200

Research contact person
Name of lead principal investigator	Takao Sugiyama
Organization	Shimosizu Hospital
Division name	Rheumatology
Address	Shikawatashi 934-5, Yotsukaido City, Chiba, Japan
TEL	043-422-2511
Email	sugiyama@simosizu2.hosp.go.jp

Public contact
Name of contact person	Kei Ikeda
Organization	Chiba University Hospital
Division name	Allergy and Clinical Immunology
Address	Inohana 1-8-1, Chiba City, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	K.Ikeda@faculty.chiba-u.jp

Sponsor
Institute	Shimosizu Hospital
Institute
Department

Funding Source
Organization	Investigators Group for Glucocorticoid Induced Osteoporosis
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	2014 Year 11 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 09 Month 27 Day
Anticipated trial start date	2010 Year 11 Month 01 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	2014 Year 11 Month 11 Day
Last modified on	2017 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018205