Overview

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