The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Not Applicable
- Conditions
- Primary osteoporosis
- Registration Number
- JPRN-UMIN000042547
- Lead Sponsor
- Koenji Orthopedics Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 88
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with a metabolic bone disease other than osteoporosis 2. Patients with a history of hypersensitivity to the study drug or BP 3. Patients who have severe renal impairment (creatinine clearance < 35 mL/min) at the start 4. Patients who are dehydrated (high fever, severe diarrhea and vomiting, etc.) at the start 5. Patients who have hypocalcemia at the start 6. Patients whom the physicians judged to be unsuitable because of idiosyncratic complications and markedly different background
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of change in the lumbar spine BMD.
- Secondary Outcome Measures
Name Time Method The rate of change in the femoral neck BMD, the changes in type I procollagen N-terminal propeptide (P1NP), tartrate-resistant acid phosphatase-5b (TRACP-5b), VAS score of back pain, Japanese Osteoporosis Quality of Life Questionnaire (JOQOL).