Effects of Denosumab Therapy for Japanese Osteoporotic Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tomidahama Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- BMD increase by denosumab in Japanese
Study Overview
Brief Summary
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of denosumab in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
The main objective of this study is to investigate effects of denosumab. The researchers also investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment. In this study, the investigators analyse the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.
Detailed Description
Registry criteria: Patients treated in the investigators hospital using denosumab. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%).
Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Osteoporotic patients
Exclusion Criteria
- •cancer, hypercalcemia, etc (i.e. patients who could not use denosumab)
Outcomes
Primary Outcomes
BMD increase by denosumab in Japanese
Time Frame: Up to 48 months
The investigators evaluate BMD increase by denosmab in Japanese patients.
Secondary Outcomes
- Effects of previous therapy to denosumab(Up to 48 months)
- The determinants related to BMD increase and fracture prevention for denosumab treatment(Up to 48 months)
Investigators
Toshihiko Kono
Head of Hospital
Tomidahama Hospital