NCT00904423

Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption

A Phase I/II Randomized, Double-blind, Controlled Study to Evaluate Efficacy and Safety of Vitamin D on Bone Mineral Density and Markers of Bone Resorption in Aromatase Inhibitor-induced Bone Loss in Women With Breast Cancer.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mark Pegram · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might be beneficial in treating these symptoms and to protect bone.

Conditions

• Breast Cancer
• Bone Diseases

Interventions

Type	Name	Description
DRUG	Vitamin D	up to 2400 mg; oral tablet

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-05-19
• Last updated: 2017-02-14
• Results posted: 2017-02-14

Locations

1 site across 1 country: United States