drugset / Trial / NCT00172172

Calcium Supplementation in Postmenopausal Women

NCT00172172

Phase 3 Completed 374 enrolled Shire
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is evaluating the effects of calcium supplementation on the efficacy and safety of recombinant parathyroid hormone (ALX1-11) in postmenopausal women with osteoporosis. The primary objective of this clinical study is to evaluate whether increases in bone mineral density (BMD) for subjects treated with ALX1-11 and receiving no calcium supplementation are less than increases in BMD observed for subjects treated with ALX1-11 and receiving calcium supplementation.

Timeline

Start
2004-01-10
Primary completion
2005-03-11
Completion
2005-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcium carbonate Other / unclassified 700 mg Oral
Subject Parathyroid Hormone Protein / enzyme biologic 100 ug Subcutaneous

Indications