drugset / Trial / NCT00471237
A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.
Timeline
- Start
- 2007-05-14
- Primary completion
- 2008-12-26
- Completion
- 2008-12-26
Publications
- Background Fitzpatrick LA, Dabrowski CE, Cicconetti G, Gordon DN, Fuerst T, Engelke K, Genant HK. Ronacaleret, a calcium-sensing receptor antagonist, increases trabecular but not cortical bone in postmenopausal women. J Bone Miner Res. 2012 Feb;27(2):255-62. doi: 10.1002/jbmr.554.
- Fitzpatrick LA, Dabrowski CE, Cicconetti G, Gordon DN, Papapoulos S, Bone HG 3rd, Bilezikian JP. The effects of ronacaleret, a calcium-sensing receptor antagonist, on bone mineral density and biochemical markers of bone turnover in postmenopausal women with low bone mineral density. J Clin Endocrinol Metab. 2011 Aug;96(8):2441-9. doi: 10.1210/jc.2010-2855. Epub 2011 May 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alendronic Acid | Small molecule | 70 mg | — |
| Subject | Ronacaleret | Unknown | 100 mg | Oral |
| Subject | Ronacaleret | Unknown | 200 mg | Oral |
| Subject | Ronacaleret | Unknown | 300 mg | Oral |
| Subject | Ronacaleret | Unknown | 400 mg | Oral |
| Comparator | Teriparatide | Protein / enzyme biologic | 20 ug | Subcutaneous |