UMIN ID: C000000001
Registered date:01/07/2005
Concurrent Treatment of Osteoporosis for Prevention of Vertebral Fracture in Japan - Multi-center Randomized Trial with Arendoronate and alfa-calcidol -
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Osteoporosis |
| Date of first enrollment | 2003/11/01 |
| Target sample size | 2140 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | alendronate(2years) alendronate+active vitaminD3(2years) |
Outcome(s)
| Primary Outcome | Incident vertebral fracture rate |
|---|---|
| Secondary Outcome | Period of incident vertebral fracture, non-vertebvral fracture rate, bone mineral density, QOL, Sreum vitamin D, safety |
Key inclusion & exclusion criteria
| Age minimum | 70years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Female |
| Include criteria | |
| Exclude criteria | Bone disease other than osteoporosis, having contraindication in using drugs, disfunction of communication of the intention, deformation of vertebra, hyperthyroidism, hyperparathyroidism, abnormal heart function, abnormal hepatic function, abnormal kidney function, taken bisphosponate within previous 6 months |
Related Information
| Primary Sponsor | Japan Osteoporosis Society/ A-TOP consortium |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Public health research foundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 1-1-7 Nishi-waseda, Shinjyuku-ku Tokyo, Japan Japan |
| Telephone | 03-5287-2633 |
| a-top@csp.or.jp | |
| Affiliation | Public health research foundation CSP-A-TOP |
| scientific contact | |
| Name | Hajime Orimo |
| Address | Kawaguchiko-cho, tsuru-gun, Yamanashi, Japan Japan |
| Telephone | |
| Affiliation | Health science university President |