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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
157
Boling Clinical Trials
Upland, California, United States
Indiana School of Medicine University Hospital
Indianapolis, Indiana, United States
Bethesda Health Research
Bethesda, Maryland, United States
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
Percent change in lumbar spine BMD (relative to baseline) at Week 52
Time frame: Baseline and Week 52
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52
The percent change in hip BMD (relative to baseline) at Week 52
Time frame: Baseline and Week 52
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52
Percent change in femoral neck BMD (relative to baseline) at Week 52
Time frame: Baseline and Week 52
Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52
Percent change in trochanter BMD (relative to baseline) at Week 52
Time frame: Baseline and Week 52
Change From Baseline in Serum Calcium Levels at Week 52
Change in serum calcium value (relative to baseline) at Week 52
Time frame: Baseline and Week 52
Percent Change From Baseline in Serum Bone Markers at Week 26
Percent change from baseline at Week 26
Time frame: Baseline and Week 26
Number of Subjects With at Least 1 Treatment-emergent Adverse Event
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.
Time frame: 1 year
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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