Unique ID issued by UMIN | UMIN000009907 |
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Receipt number | R000011486 |
Scientific Title | Safety and efficacy of teriparatide in dialysis patients with osteoporosis |
Date of disclosure of the study information | 2013/01/30 |
Last modified on | 2015/08/03 08:59:46 |
Safety and efficacy of teriparatide in dialysis patients with osteoporosis
Teriparatide for dialysis patients with osteoporosis
Safety and efficacy of teriparatide in dialysis patients with osteoporosis
Teriparatide for dialysis patients with osteoporosis
Japan |
low-PTH osteoporosis in dialysis patients
Endocrinology and Metabolism | Nephrology |
Others
NO
To clarify the safety and efficacy of teriparatide treatment for low- PTH osteoporosis with dialysis patients
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Change of bone mineral density
Change of serum marker related to bone metabolism.
Incidence of bone fracture after teriparatide therapy.
Incidence of lumbago and abdominal pain.
Side-effect and tolerance rate
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1. Intact PTH lower than 60 pg/ml
2. Osteoporosis (T score <-2.5)
3. Low bone mass (T-score between -1.0 and -2.5 at the femoral neck or spine) with fragility fracture, with family history of proximal femur fracture, or with more than 15% of FRAX score (10-year probability of a major osteoporosis-related fracture).
1. Dialysis vintage less than 1 year
2. Patietns with Paget's disease or having high alkaline phosphatase.
3. Previous history of radiation therapy affecting bone.
4. Bone related malignancy, including bone metastasis
30
1st name | |
Middle name | |
Last name | Kenmei Takaichi |
Toranomon Hospital
Nephrology Center
2-2-2, Toranomon, Minato-ku, Tokyo
03-3588-1111
takaichi@toranomon.gr.jp
1st name | |
Middle name | |
Last name | Junichi Hoshino |
Toranomon Hospital
Nephrology Center
2-2-2, Toranomon, Minato-ku, Tokyo
+81-3-3588-1111
hoshino@toranomon.gr.jp
Nephrology Center, Toranomon Hospital
none
Self funding
none
none
NO
虎の門病院(東京都)、虎の門病院分院(神奈川県)
2013 | Year | 01 | Month | 30 | Day |
Partially published
Completed
2013 | Year | 01 | Month | 30 | Day |
2013 | Year | 01 | Month | 30 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 02 | Month | 01 | Day |
2015 | Year | 05 | Month | 31 | Day |
prospective cohort study
2013 | Year | 01 | Month | 30 | Day |
2015 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011486
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