Primary Osteoporosis
Conditions
Interventions
LOX+ZOL group: Patient takes loxoprofen sodium hydrate 60mg
twice on the day of administration of zoledronic acid, three times in the next day.
ZOL group: Patient takes loxoprofen sodium hydrate 60mg as rescue medicine.
Sponsors
OZ-study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Primary osteoporosis patient (2) Japanese patient aged over 60 years old at informed consent (3) Patient whose history of usage of osteoporotic therapeutic drug in past three years before informed consent can be investigated
Exclusion criteria
Exclusion criteria: (1) Secondary osteoporosis patient (2) Patient has serious renal disease: creatinine clearance< 35ml/min, or serious liver disease or serious heart disease (3) Patient has complication or history of malignant tumor in past five years (4) Patient has history of hypersensitivity to zoledronic acid or other kinds of bisphosphonate or loxoprofen sodium hydrate (5) Patient with hypocalcemia (6) Patient participated in other clinical trials within 24 weeks before informed consent (7) Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute phase reaction (pyrexia, arthralgia, myalgia, headache,influenza-like illness) Body temperature (>=1 degrees Celsius from baseline and >=37.5 degrees Celsius) | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between osteoporosis therapeutic use history in past three years and APR, changes in body temperature | — |
Countries
Japan
Contacts
Public ContactTeruhiko Miyazaki
Public Health Research Foundation Comprehensive Support Project
Outcome results
None listed