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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deltanoid Pharmaceuticals
• Treatments: Bone Density Conservation Agents; Dihydroxycholecalciferols; Ergocalciferols; Retinol palmitate; Vitamin A; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Postmenopausal female subjects, defined as amenorrheic for at least 5 years

• Body Mass Index of 18 to 35

• Osteopenic

• Generally healthy

• Informed consent

Exclusion Criteria

• 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