Unique ID issued by UMIN | UMIN000009222 |
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Receipt number | R000010829 |
Scientific Title | Drug therapy for the prevention of glucocorticoid induced osteoporosis in elderly patients: teriparatide or bisphosphonates? |
Date of disclosure of the study information | 2012/11/01 |
Last modified on | 2018/08/09 14:25:18 |
Drug therapy for the prevention of glucocorticoid induced osteoporosis in elderly patients: teriparatide or bisphosphonates?
Drug therapy for glucocorticoid induced osteoporosis in elderly patients
Drug therapy for the prevention of glucocorticoid induced osteoporosis in elderly patients: teriparatide or bisphosphonates?
Drug therapy for glucocorticoid induced osteoporosis in elderly patients
Japan |
glucocorticoid-induced osteoporosis
Medicine in general | Endocrinology and Metabolism | Clinical immunology |
Geriatrics |
Others
NO
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).
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
Symptomatic vertebral fractures, those are determined by conventional thoracic and spinal radiographs in lateral and antero-posterior projections at any time during study.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
NO
No need to know
2
Treatment
Medicine |
Bisphosphonate group: receive alendronate 35 mg/week or risedronate 17.5 mg/week for 24 months
Teriparatide group; 0.002mg/day subcutaneouly for 24 months
65 | years-old | <= |
Not applicable |
Male and Female
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.
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.
40
1st name | |
Middle name | |
Last name | Koichi Amano |
Saitama Medical Center,
Saitama Medical University
Department of Rheumatology and Clinical Immunology
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
049-228-3859
amanokoi@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Hirofumi Takei |
Saitama Medical Center, Saitama Medical Universitity
Department of Rheumatology & Clinical Immunology
1981 Kamoda Kawagoe, Saitama 350-8550
049-228-3859
takeix@saitama-med.ac.jp
Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity
Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity
Self funding
NO
2012 | Year | 11 | Month | 01 | Day |
Unpublished
No longer recruiting
2012 | Year | 12 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 04 | Month | 30 | Day |
2019 | Year | 05 | Month | 31 | Day |
2019 | Year | 06 | Month | 30 | Day |
2012 | Year | 10 | Month | 30 | Day |
2018 | Year | 08 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010829
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