Unique ID issued by UMIN | UMIN000025799 |
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Receipt number | R000029671 |
Scientific Title | Effects of monthly injected ibandronate on bone mineral density and microstructure in patients with primary osteoporosis after teriparatide treatment. |
Date of disclosure of the study information | 2017/01/26 |
Last modified on | 2020/07/31 12:28:34 |
Effects of monthly injected ibandronate on bone mineral density and microstructure in patients with primary osteoporosis after teriparatide treatment.
Effects of injected ibandronate with primary osteoporosis after teriparatide treatment.
MONUMENT Study
Effects of monthly injected ibandronate on bone mineral density and microstructure in patients with primary osteoporosis after teriparatide treatment.
Effects of injected ibandronate with primary osteoporosis after teriparatide treatment.
MONUMENT Study
Japan |
Primary osteoporosis
Orthopedics |
Others
NO
Investigate the effects of ibandronate with primary osteoporosis after teriparatide treatment.
Efficacy
Confirmatory
Pragmatic
Changing rates of bone mineral density from start to 12months after.
1)Changing rates of bone mineral density of lumbar from start to 6 months after.
2)Areal bone mineral density of femur and distal radius,Changing rates of SOS in Calcaneus,Incidences of vertebral fracture,Meaturemenst of Bone turnover markers,Changing rates of Visual Analog Scale,Microarchitectures of cotical bone and cancellous bone,Changing rates of predictive bone stiffness,Changinn rates of femur morphology.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
monthly injected ibandronate
55 | years-old | <= |
Not applicable |
Female
1 Primary osteoporosis patients received teriparatide 12months or more.
2 The patients who are able to receive ivandronate within 8weeks from teriparatide treatments.
3 Age:55 years and over
4 Gender:female
5 Out patients
6 Patients who agree with the documents.
1 Patients with a history of critical heart disease, hepatic disease, kidney disease, diabetes mellitus, cancer, endcrine disease, metabolic disease, and secondary osteoporosis.
2 Patients taking steroids more than 5mg, and drugs affecting bone metabolism.
3 Patients with a history of allergy to ibandronate or bisphosphonate and hypocalcemia.
4 Patients with a history of Participation in clinical trials.
5 More than 3 vertebral fractures between L1 toL4.
6 Patients judged inappropriate by author.
66
1st name | Makoto |
Middle name | |
Last name | Osaki |
Nagasaki University graduate school of biomedical sciences
Department of orthopaedic surgery
852-8501
1-7-1 Sakamoto Nagasaki 852-8501
095-819-7321
mosaki@nagasaki-u.ac.jp
1st name | Ko |
Middle name | |
Last name | Chiba |
Nagasaki University Hospital
Department of orthopaedic surgery
852-8501
1-7-1 Sakamoto Nagasaki 852-8501
095-819-7321
kohchiba@estate.ocn.ne.jp
Nagasaki University Hospital Department of Orthopaedic Surgery
Chugai Pharmaceutical Co., Ltd.
Profit organization
Japan
Nagasaki University Clinical Research Review Board
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
095-819-7905
gaibushikin@ml.nagasaki-u.ac.jp
NO
長崎大学病院(長崎県) Nagasaki University Hospital
2017 | Year | 01 | Month | 26 | Day |
Unpublished
Completed
2017 | Year | 01 | Month | 23 | Day |
2017 | Year | 01 | Month | 24 | Day |
2017 | Year | 02 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 01 | Month | 23 | Day |
2020 | Year | 07 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029671
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