An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase I/II Randomized Study of the Short-Term Effects of APOMINE vs Placebo in Postmenopausal Women With Osteoporosis or Low Bone Mass|
- Osteoporosis/low bone mass subjects treated with 3 levels (25, 50 or 100 mg/day) of Apomine or placebo. Efficacy measured by changes in baseline in: biochemical indicators of bone formation and bone resorption and BMD.
- To evaluate the quantitative and qualitative toxicities, as well as limited pharmacokinetics in this population.
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||December 2004|
This study is a randomized, placebo-controlled, double-blind, parallel-group study to investigate the efficacy and safety of administering 3 dose levels of APOMINE at 25, 50, or 100 mg/day or placebo once a day as a capsule to postmenopausal women with low bone mass or osteoporosis. Eligible patients must be women between 45 and 75 years of age, have a diagnosed low bone mineral density or osteoporosis, and be at least 3 years post menopause. The primary endpoint of the study will be changes in bone formation markers (bone alkaline phosphatase and osteocalcin). The secondary endpoint of the study will be changes in bone formation markers (bone alkaline phosphatase, osteocalcin, and P-ICP) and bone resorption markers (serum C-telopeptide, urinary N-telopeptide). Blood samples will be drawn at each study visit to determine these bone markers as well as for normal laboratory tests. Bone mineral density measurements (DEXA) will be performed at the beginning and at the end of the study. Up to 60 subjects will be randomized as a cohort for treatment and treated with 25, 50, or 100 mg/day or placebo (15 subjects per group). All enrolled subjects will receive a daily calcium and Vitamin D supplement.
|United States, Nebraska|
|Omaha, Nebraska, United States|
|United States, New York|
|West Haverstraw, New York, United States|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|