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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 2, Double-blind, Randomized, Placebo-Controlled, Daily-dose, Proof-of-concept Study of a Vitamin D Compound in Postmenopausal Women With Osteopenia

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Placebo
* Drug: DP001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br> | Drug: Placebo<br>* oral, once daily<br>|
| Experimental: Group 2<br>220 ng | Drug: DP001<br>* oral, once daily<br>* Other names: 2MD;|
| Experimental: Group 3<br>440 ng | Drug: DP001<br>* oral, once daily<br>* Other names: 2MD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline and Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Baseline and Week 52 | 
| Percent Change From Baseline in Serum Bone Markers at Week 26 | Percent change from baseline at Week 26 | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, Vitamin D, Bone Density Conservation Agents, Bone Regeneration