Effect of minodronate for preventring secondary fragility fractures in postoperative hip fractures of oseteoporotic patients.
Not Applicable
- Conditions
- Osteoporosis
- Registration Number
- JPRN-UMIN000018492
- Lead Sponsor
- agano Red Cross Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
1.Have 3 or more vertebral fractures between L1 and L4 or history of hip fracture. 2.Have peptic ulcers. 3.Have history of gastrectomy or broad gastrointestinal resection. 4.Have diseases that are likely to delay esophageal transit such as esophagus stenosis or achalasia. 5.Cannot keep upright or sitting positioning for 30 minutes or more which taking drug. 6.Have history of severe drug allergy of minodronate or eldecalcitol. 7.Have corrected serum calcium on the latest laboratory result. 8.Have severe hepatic and renal dysfunction and cardiovascular disease. 9.Pregnant females or females who plan to be pregnant. 10.Judged inappropriate to participate the study by attending physicians.
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Incidence rate of osteoporotic fragility fracture. 2.Percentage change in lumbar spine and proximal femoral bone mineral density
- Secondary Outcome Measures
Name Time Method 1.Serum bone resorption marker (TRACP-5b: Tartrate resistant acid phosphatase-5b) 2.Serum bone formation marker (P1NP: aminoterminal propeptide of type I collagen) 3.Serum bone matrix marker (Homocysteine, Pentosidine) 4.Change of laboratory values (Ca, AST, ALT, ALP, serum creatinine, and so on.) 5.Improvement of QOL (SF-8) 6.Medication persistence rate of minodronate and incidence rate of adverse event.