Primary osteoporosis
Conditions
Interventions
Single injection of once-yealy zoledronic acid hydrate(5mg) with daily eldecalcitol(0.75microgram) and Calcium L-apapartate(600mg) for 12 months
Sponsors
Ainomemorial hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative change of lumbar bone mineral density after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTakayuki Nakamura
Ainomemorial hospital Department of orthopeadic surgery
Outcome results
None listed