A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.

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

Outcome

Met primary endpoint

Stopped: “Terminated for futility by sponsor after a pre-planned interim review of data”

registry analysis (superiority test); Placebo vs Ronacaleret, 200 mg Tablet, OD; p = 0.028; Mean Difference (Net) 1.36 (95% CI 0.28 to 2.44); ANOVA NCT00471237 ↗

registry analysis (superiority test); Placebo vs Ronacaleret, 300 mg Tablet, OD; p = 0.011; Mean Difference (Net) 1.58 (95% CI 0.51 to 2.65); ANOVA NCT00471237 ↗

registry analysis (superiority test); Placebo vs Ronacaleret, 400 mg Tablet, OD; p = 0.012; Mean Difference (Net) 1.60 (95% CI 0.51 to 2.69); ANOVA NCT00471237 ↗

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

Indications