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

Phase 2

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52	Baseline and Week 52	Percent change in lumbar spine BMD (relative to baseline) at Week 52

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52	Baseline and Week 52	The percent change in hip BMD (relative to baseline) at Week 52
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52	Baseline and Week 52	Percent change in femoral neck BMD (relative to baseline) at Week 52
Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52	Baseline and Week 52	Percent change in trochanter BMD (relative to baseline) at Week 52
Change From Baseline in Serum Calcium Levels at Week 52	Baseline and Week 52	Change in serum calcium value (relative to baseline) at Week 52
Percent Change From Baseline in Serum Bone Markers at Week 26	Baseline and Week 26	Percent change from baseline at Week 26
Number of Subjects With at Least 1 Treatment-emergent Adverse Event	1 year	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.

Locations (9): Boling Clinical Trials
🇺🇸
Upland, California, United States
Bethesda Health Research
🇺🇸
Bethesda, Maryland, United States
Creighton University Bone Metabolism Unit
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Omaha, Nebraska, United States
New Mexico Clinical Research and Osteoporosis Center
🇺🇸
Albuquerque, New Mexico, United States
Indiana School of Medicine University Hospital
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Indianapolis, Indiana, United States
Helen Hayes Hospital Clinical Research Center
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West Haverstraw, New York, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
Winthrop University Hospital Bone Mineral Research Center
🇺🇸
Mineola, New York, United States
University of Wisconsin-Madison Osteoporosis Clinical Research
🇺🇸
Madison, Wisconsin, United States