A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)

Phase 2 Terminated 383 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to identify an appropriate dose of MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

Timeline

Start: 2009-10
Primary completion: 2010-12
Completion: 2010-12

Outcome

Missed primary endpoint

paper However, there were no increases in BMD versus placebo. PMID 25166719 ↗

registry MK-5442 15 mg vs Placebo; p = 0.749; LS Mean Difference in Change From BL 0.56 (95% CI -1.04 to 2.16) NCT00960934 ↗

Publications

Results Halse J, Greenspan S, Cosman F, Ellis G, Santora A, Leung A, Heyden N, Samanta S, Doleckyj S, Rosenberg E, Denker AE. A phase 2, randomized, placebo-controlled, dose-ranging study of the calcium-sensing receptor antagonist MK-5442 in the treatment of postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2014 Nov;99(11):E2207-15. doi: 10.1210/jc.2013-4009. Epub 2014 Aug 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Encaleret	Small molecule	2.5 mg	Oral
Subject	Encaleret	Small molecule	5 mg	Oral
Subject	Encaleret	Small molecule	7.5 mg	Oral
Subject	Encaleret	Small molecule	10 mg	Oral
Subject	Encaleret	Small molecule	15 mg	Oral