drugset / Trial / NCT00433160
Phase 3 Clinical Trial of Teriparatide in Japan
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
Timeline
- Start
- 2007-01
- Primary completion
- 2008-09
- Completion
- 2009-09
Outcome
Met primary endpoint
paper teriparatide significantly increased bone mineral density (BMD) at the lumbar spine L2-L4 PMID 20580870 ↗
registry Teriparatide vs Placebo; p <0.001; t-test, 2 sided NCT00433160 ↗
Publications
- Results Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.
- Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Teriparatide | Protein / enzyme biologic | 20 ug | Subcutaneous |