Osteoporosis
Conditions
Interventions
minodronate 50mg once 4 weeks(min group)
no treatment of minedronate (control)
Sponsors
Nagano Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese osteoporotic patients who aged over 50 years old, who was postoperative fragility hip fracture, and who provided consent to participate in the study.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Incidence rate of osteoporotic fragility fracture. 2.Percentage change in lumbar spine and proximal femoral bone mineral density | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMasatoshi Hayashi
Nagano Red Cross Hospital orthopaedics
Outcome results
None listed