UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Drug therapy for the prevention of glucocorticoid induced osteoporosis in elderly patients: teriparatide or bisphosphonates?
Title of the study (Brief title)	Drug therapy for glucocorticoid induced osteoporosis in elderly patients
Region	Japan

Condition
Condition	glucocorticoid-induced osteoporosis
Classification by specialty	Medicine in general Endocrinology and Metabolism Clinical immunology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the efficacy of teriparatide and bisphosphoonates for the prevention of symptomatic vertebral fracture in elderly patients (more than 65 years old) with collagen vascular diseases who will be or have been treated with glucocorticoid (more than 10 mg/day of prednisolone).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at any time during study.
Key secondary outcomes	Non symptomatic vertebral fractures and non-vertebral fractures deetermined by plain X-ray. Bone mineral density values, those are measured at the lumbar spine. The serum levels of NTX, osteocalcin, 25(OH)vitamin D, growth hormone (GH) and IGF-1.

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
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Bisphosphonate group: receive alendronate 35 mg/week or risedronate 17.5 mg/week for 24 months
Interventions/Control_2	Teriparatide group; 0.002mg/day subcutaneouly for 24 months
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	Patients who are initially treated with more than 10 mg/day of glucocorticoid (prednisolone) for more than 3 months or scheduled to be treated for more than 3 months.
Key exclusion criteria	1) Patients who have serious renal disorder (egfr < 35 ml /min or cr > 1.5 mg/ml). 2)Patient who has a history of renal stone past 5 years. 3)Patients with primary or secondary hyperparathyroidism. 4)Patients with hyperthyroidism or hypothyroidism. 5)Patients who are considered to be contraindicated for bisphosphonates or teriparatide. 6)Patients who are treated with warfarin. 7)Patients who have experiences of receiving drugs having influence on bone remodeling within 6 months at inclusion of the study (pth,bisphosphonates, estrogen , vitamin d3, vitamin k2, serm (raloxifene, bazedoxifene), calcitonin, Ipriflavone, steroids) 8) Patients who are thought to be inappropriate for this study by physician.
Target sample size	40

Research contact person
Name of lead principal investigator	Koichi Amano
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Rheumatology and Clinical Immunology
Address	1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL	049-228-3859
Email	amanokoi@saitama-med.ac.jp

Public contact
Name of contact person	Hirofumi Takei
Organization	Saitama Medical Center, Saitama Medical Universitity
Division name	Department of Rheumatology & Clinical Immunology
Address	1981 Kamoda Kawagoe, Saitama 350-8550
TEL	049-228-3859
Homepage URL
Email	takeix@saitama-med.ac.jp

Sponsor
Institute	Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity
Institute
Department

Funding Source
Organization	Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity
Organization
Division
Category of Funding Organization	Self funding
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	2012 Year 11 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 12 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 04 Month 30 Day
Date trial data considered complete	2019 Year 05 Month 31 Day
Date analysis concluded	2019 Year 06 Month 30 Day

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

Management information
Registered date	2012 Year 10 Month 30 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010829