Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoporosis

In brief

This study will evaluate the effect of a 1-year administration of the vitamin D analog 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density (BMD), safety, and tolerability.

Key facts

Study ID

NCT00715676

Run by

Deltanoid Pharmaceuticals

People needed

157

Starts

2007-03-01

Expected to finish

2009-01-01

Last updated by the study team

2010-01-11

Who can join

Age: 55 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal female subjects, defined as amenorrheic for at least 5 years
• Body Mass Index of 18 to 35
• Osteopenic
• Generally healthy
• Informed consent

You may not qualify if…

• History or evidence of acute or unstable chronic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases
• Current or recent treatment with any medications or products affecting vitamin D metabolism, calcium balance, bone turnover, or an investigational drug therapy
• 12-lead electrocardiogram demonstrating QTc (QT interval corrected for heart rate) >450 milliseconds at screening
• Abnormal creatinine clearance
• Elevated urinary calcium levels
• Vitamin D deficiency
• Excessive dietary calcium or vitamin D intake
• Current use of any illicit drug and/or history of alcohol abuse

Where it is running

• Boling Clinical Trials — Upland, California, United States
• Indiana School of Medicine University Hospital — Indianapolis, Indiana, United States
• Bethesda Health Research — Bethesda, Maryland, United States
• Creighton University Bone Metabolism Unit — Omaha, Nebraska, United States
• New Mexico Clinical Research and Osteoporosis Center — Albuquerque, New Mexico, United States
• Winthrop University Hospital Bone Mineral Research Center — Mineola, New York, United States
• Helen Hayes Hospital Clinical Research Center — West Haverstraw, New York, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• University of Wisconsin-Madison Osteoporosis Clinical Research — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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