Osteoporosis
Conditions
Interventions
Test drug (24 weeks),Control drug (24 weeks) [Test drug (once 4-weekly BP)] Minodronic acid hydrate (Recalbon or Bonoteo tablets) 50mg [Control drug (once-weekly BP)] Alendronate tablets 35mg
Sponsors
Yamaguchi university graduate school of medicine, Department of orthopedic surgery
ONO PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Primary osteoporotic patients 2)Patients who did not take bisphosphonate more than 6 months before this trial 3)Age-lower limit: 50 years old, age-higher limit: none 4)Patients who passed after the menopause for two years or more before informed consent 5)Hospitalization/outpatient: no object
Exclusion criteria
Exclusion criteria: 1)Secondary osteoporotic patient and patients who had disorders such as other causes of low bone mineral density 2)Patients who had history of gastrectomy or broad gastrointestinal resection 3)Patients who diagnosed malignancy 4)Patients who had history of radiation to lumber or pelvic section 5)Patients who had an observation affecting bone mineral density using DXA 6)Patients who received therapy of IV bisphosphonate 7)Patients who received therapy of strontium or parathyroid hormone 8)Patients who took calcitonin within a month before this trial 9)Patients who is receiving therapy of oral steroid 10)Patients who is receiving therapy of biologics or DMARDs 11)Patients who have obstacles which delays esophagus passage of stricture of the esophagus or achalasia 12)Patients who have raised the upper part of the body for 30 minutes or it cannot be standing 13)Patients who have serum calcium levels 10.6 or more mg/L 14)Patients who have serum calcium levels 8.0 or less mg/L 15)Patients who have severe renal dysfunction (creatinine clearance levels below 30 mL/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change L2-4 BMD using DXA and bone turnover maker (TRACP-5b) are analyzed separately for baseline to 24-week and 48-week. | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL and VAS are measured at baseline , 24-week and 48-week after treatment. Patient preference is assessed at 48 weeks after treatment. | — |
Countries
Japan
Contacts
Public ContactTakashi Imagama
Yamaguchi university graduate school of medicine Orthopedic Surgery
Outcome results
None listed