A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

Summary

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Timeline

Start

2008-06

Primary completion

2010-07

Completion

2010-07

Outcome

Met primary endpoint

registry NUMBER FOSAVANCE 5600: 8.6 Percentage of Participants NUMBER Referred-Care: 31.0 Percentage of Participants NCT00692913 ↗

registry analysis (unspecified test); FOSAVANCE 5600 vs Referred-Care; p <0.001; Odds Ratio (OR) 0.20 (95% CI 0.12 to 0.35); Regression, Logistic NCT00692913 ↗

Publications

• Background Ralston SH, Binkley N, Boonen S, Kiel DP, Reginster JY, Roux C, Chen L, Rosenberg E, Santora A; FOCUS-D (FOSAVANCE vs. Standard Care-Use and Study of Vitamin D) Trial. Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency. Calcif Tissue Int. 2011 Jun;88(6):485-94. doi: 10.1007/s00223-011-9482-4. Epub 2011 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alendronic Acid	Small molecule	70 mg	—
Subject	Cholecalciferol	Other / unclassified	5600 iu	—

Indications