drugset / Trial / NCT00078026

An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass

NCT00078026 ↗

Phase 1/2 Terminated 60 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupDouble-blindTreatment

Summary

Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.

Timeline

Start
2003-08
Primary completion
—
Completion
2004-12

Drugs

EvaluationDrugModalityDoseRoute
Subject apomine Small molecule 25 mg Oral
Subject apomine Small molecule 50 mg Oral
Subject apomine Small molecule 100 mg Oral