Unique ID issued by UMIN | UMIN000025865 |
---|---|
Receipt number | R000029739 |
Scientific Title | Effects of once-yearly injected zoledronic acid hydrate on bone mineral density in patients with primary osteoporosis after daily teriparatide treatment |
Date of disclosure of the study information | 2017/02/28 |
Last modified on | 2017/03/12 10:38:41 |
Effects of once-yearly injected zoledronic acid hydrate on bone mineral density in patients with primary osteoporosis after daily teriparatide treatment
Effects of zoledronate therapy in patients with primary osteoporosis after teriparatide treatment
Effects of once-yearly injected zoledronic acid hydrate on bone mineral density in patients with primary osteoporosis after daily teriparatide treatment
Effects of zoledronate therapy in patients with primary osteoporosis after teriparatide treatment
Japan |
Primary osteoporosis
Orthopedics | Adult |
Others
NO
Single zoledronic acid hydrate will be injected once a year to patients with primary osteoporosis after more than 12 months of daily teriparatide treatment. The purpose of this study is to evaluate effects, such as bone mineral density, bone metabolic markers, and new bone fracture, after 12 months of single zoledronic acid therapy.
Efficacy
Quantitative change of lumbar bone mineral density after 12 months
1) Quantitative change of lumbar bone mineral density after 6 months
2) Quantitative change of femoral bone mineral density, new vertebral body fracture incidence and guantitative change of bone metabolic markers after 6 and 12 months
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Single injection of once-yealy zoledronic acid hydrate(5mg) with daily eldecalcitol(0.75microgram) and Calcium L-apapartate(600mg) for 12 months
55 | years-old | <= |
Not applicable |
Female
1)Patients treaed by daily teriparatid treatment for more than 12 months
2)Patients who can take zoledronic acid hydrate within 8 weeks after last daily subcutaneous teriparatid injection
3)Age: more than 55 yaers-old when we get consent
4)Sex: Female
5)Out patients
6)Patients after receiving explanation upon participation in this study, on the thorough understanding, that document consent is obtained by the free will of the study in person
1)Anaphylaxis or any history of hypersensitivity to zoledronic acid and other kinds of bisphosnate
2)Serious renal dysfunction: creatinine clearance< 35ml/min
3) Serious heart disease, serious liver dysfunction, diabetes mellitus
4)Endocrine and metabolic disaease which may affect to the bone metabolism, and secondary osteoporosis(e.g. glucocorticoide-induced osteoporosis, rheumatoid arthiritis, immobilization osteoporosis)
5) Patients treated with medication which affect to the bone metabolism as follows,
i)Glucocorticosteroids(more than 5mg for over 3 months) except inhaler or nasal drugs
ii) Anticancer drugs
6) Patient of the hypocalcemia
7) A pregnant woman or the woman who might be pregnant
8)Patients who was diagnosed all of the L2, L3 and L4 vertebral fractures before zolendronate injection
9)Ptients who were jugged to be inadequate for this study by investigators
45
1st name | |
Middle name | |
Last name | Eiji Kaida |
Ainomemorial hospital
Department of orthopeadic surgery
3838-1 Kou, Aino,Unzen city, Nagasaki prefecture, Japan
0957-36-0015
ei2kaida@ainomhop.jp
1st name | |
Middle name | |
Last name | Takayuki Nakamura |
Ainomemorial hospital
Department of orthopeadic surgery
3838-1 Kou, Aino,Unzen city, Nagasaki prefecture, Japan
0957-36-0015
tkyknkmr78@yahoo.co.jp
Ainomemorial hospital
Ainomemorial hospital
Self funding
NO
2017 | Year | 02 | Month | 28 | Day |
Unpublished
Open public recruiting
2017 | Year | 01 | Month | 26 | Day |
2017 | Year | 02 | Month | 01 | Day |
2017 | Year | 01 | Month | 26 | Day |
2017 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029739