Unique ID issued by UMIN | UMIN000012362 |
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Receipt number | R000014450 |
Scientific Title | A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy |
Date of disclosure of the study information | 2013/11/21 |
Last modified on | 2017/05/24 11:36:57 |
A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy
A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy (SMUIM4-NHL01)
A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy
A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy (SMUIM4-NHL01)
Japan |
Malignant Lymphoma
Hematology and clinical oncology |
Malignancy
NO
Evaluating the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapy
Safety,Efficacy
Change in bone mineral density
Change in bone metabolism markers
Incidence rate of pathological bone fracture
Adverse events
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Treatment
Medicine |
Malignant lymphoma patients with osteoporosis will be administered with 60 mg of denosumab once within one week before the start of prednisolone-containing chemotherapy and with calcium and Vitamin D daily.
Malignant lymphoma patients without osteoporosis will not be administered with denosumab.
20 | years-old | <= |
90 | years-old | >= |
Male and Female
PS 0-2
Aged ≥20 and ≤90
Patients whose prognosis would be expected more than 3 months
Written informed consent
Uncontrolled hepatic disease, renal disease, heart disease, lung disease, diabetes mellitus, hypertention and infectious disease
Active concomitant malignancy
Severe psychiatric disorders
Women who are pregnant or in lactation
Hypersensitivity to the denosumab
Dental therapy during this trial
Current hypocalcemia
Patient judged inappropriate for this study by the physicians
30
1st name | |
Middle name | |
Last name | Tsutomu Sato |
Sapporo Medical University Hospital
Fourth Department of Internal Medicine
S-1, -16, Chuo-ku, Sapporo
011-611-2111
tsutomus@sapmed.ac.jp
1st name | |
Middle name | |
Last name | Tsutomu Sato |
Sapporo Medical University Hospital
Fourth Department of Internal Medicine
S-1, -16, Chuo-ku, Sapporo
011-611-2111
tsutomus@sapmed.ac.jp
Department of Medical Oncology and Hematology, Sapporo Medical University, School of Medicine
None
Self funding
NO
2013 | Year | 11 | Month | 21 | Day |
Unpublished
Completed
2013 | Year | 11 | Month | 21 | Day |
2013 | Year | 11 | Month | 21 | Day |
2013 | Year | 11 | Month | 20 | Day |
2017 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014450
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