osteoporosis
Conditions
Interventions
Single-arm study with first12 months treated with Bazedoxifene 20mg/day and vitamin D 0.0005-0.001mg/day and further 6 months treated with vitamin D only
Sponsors
Gerontology Osaka City University
Kousai-in Municipal Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients with postmenopausal osteoporosis, or patients with high risk of fracture as defined by the guideline (Japanese guidelines for the prevention and treatment of osteoporosis 2006 edition) that are undergoing treatment with active vitamin D(Alfacalcidol 0.0005-0.001mg/day) for at least 6 months
Exclusion criteria
Exclusion criteria: (1) Patients treated with bisphosphonates over 2 weeks within the previous 12 months; (2) Patients that had been treated with medications that may affect bone metabolism within the previous 3 months with exception to calcium and vitamin D; (3) Patients with allergic reaction to SERM or contraindication to SERM; (4) Patients with kidney dysfunction (serum creatinine >1.6mg/dl); (5) Acute phase of fracture; (6) Immobility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of TRACP-5b after Bazedoxifene treatment at 6 months compared with other markers. | — |
Secondary
| Measure | Time frame |
|---|---|
| TRACP-5b change at 6th month after Bazedoxifene discontinuation Changes of lumbar BMD and femoral neck BMD form baseline Changes of the other bone markers from baseline Changes of lipid profiles from baseline | — |
Countries
Japan
Contacts
Public ContactHideki Masaki
Osaka City University Gerontology
Outcome results
None listed