Osteoporosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. RA patients with osteoporosis taking BPs for at least three months 2. Patients with RA for at least six months
Exclusion criteria
Exclusion criteria: 1. Patients who underwent rheumatoid arthritis surgery less than three months before entry 2. Patients experienced any fracture less than three months before surgery 3. Patients with active RA and inadequate response to treatment 4. Patients with peptic ulcers 5. Patients with esophageal stricture or achalasia 6. Patients unable to remain upright for 30 min after dosing 7. Patients with hypocalcaemia 8. Females with pregnancy and lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Changes in bone mineral density (2) Changes TRACP-5b, CTX, P1NP, BAP, uDPD, ucOC, MMP-3, CRP, 1,25(OH)2VtD, serumCa, and serumP | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) MHAQ (2) mini-JOQOL (3) Patient Satisfaction Questionnaire (4) Treatment adherence (5) Side effects (6) Incident fracture | — |
Countries
Japan
Contacts
Osaka University Graduate School of Medicine Department of Orthopaedic Surgery