A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Phase 4 Completed 219 enrolled Organon and Co

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.

Timeline

Start: 2011-06-19
Primary completion: 2013-01-10
Completion: 2013-01-10

Outcome

Met primary endpoint

registry analysis (unspecified test); Fosamax Plus vs Calcitriol; p <0.001; Estimated Difference 1.95 (95% CI 0.8 to 3.1) NCT01350934 ↗

registry analysis (unspecified test); Fosamax Plus vs Calcitriol; p <0.001; Estimated Difference 2.92 (95% CI 1.8 to 4.1) NCT01350934 ↗

Publications

Results Zhang ZL, Liao EY, Xia WB, Lin H, Cheng Q, Wang L, Hao YQ, Chen DC, Tang H, De Peng Y, You L, He L, Hu ZH, Song CL, Wei F, Wang J, Zhang L, Santora AC. Alendronate sodium/vitamin D3 combination tablet versus calcitriol for osteoporosis in Chinese postmenopausal women: a 6-month, randomized, open-label, active-comparator-controlled study with a 6-month extension. Osteoporos Int. 2015 Sep;26(9):2365-74. doi: 10.1007/s00198-015-3141-y. Epub 2015 May 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alendronic Acid	Small molecule	70 mg	Oral
Comparator	Calcitriol	Small molecule	0.25 ug	Oral
Subject	Cholecalciferol	Other / unclassified	5600 iu	Oral