Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
A Phase 2, Double-blind, Randomized, Placebo-Controlled, Daily-dose, Proof-of-concept Study of a Vitamin D Compound in Postmenopausal Women With Osteopenia
Lead SponsorDeltanoid Pharmaceuticals
StatusCompleted Results Posted
Intervention/Treatment2-methylene-19-nor-(20s)-1,25-dihydroxyvitamin d3 ...
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.
DP001 is a vitamin D analog that has been shown to stimulate bone formation in pre-clinical studies. In a Phase 1B study of postmenopausal women, an increase in the bone formation marker, osteocalcin, was evident without an increase in serum calcium. The aim of this study is to determine if 1-year administration of DP001 to postmenopausal women with osteopenia results in a significant increase in BMD at doses that are safe and well tolerated.
oral, once daily
oral, once daily
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
|Event Type||Organ System||Event Term||Placebo||220 ng DP001||440 ng DP001|
Percent change in lumbar spine BMD (relative to baseline) at Week 52
The percent change in hip BMD (relative to baseline) at Week 52
Percent change in femoral neck BMD (relative to baseline) at Week 52
Percent change in trochanter BMD (relative to baseline) at Week 52
Change in serum calcium value (relative to baseline) at Week 52
Percent change from baseline at Week 26
To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.