An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass
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|ClinicalTrials.gov Identifier: NCT00078026|
Recruitment Status : Terminated
First Posted : February 19, 2004
Last Update Posted : February 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Apomine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||August 2003|
|Study Completion Date :||December 2004|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078026
|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|