Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density (2MD-3H-2B)

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Placebo; Drug: DP001

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.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Upland, California, United States, 91786
      • Boling Clinical Trials
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana School of Medicine University Hospital
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Bethesda Health Research
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University Bone Metabolism Unit
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clinical Research and Osteoporosis Center
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital Bone Mineral Research Center
    • West Haverstraw, New York, United States, 10993
      • Helen Hayes Hospital Clinical Research Center
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison Osteoporosis Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1	Drug: Placebo; oral, once daily
Experimental: Group 2; 220 ng	Drug: DP001; oral, once daily; Other Names: 2MD; 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3
Experimental: Group 3; 440 ng	Drug: DP001; oral, once daily; Other Names: 2MD; 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Deltanoid Pharmaceuticals
• Investigators: Study Director: Wendy A Bedale, Ph.D., Deltanoid Pharmaceuticals

Publications and helpful links

General Publications

• Ke HZ, Qi H, Crawford DT, Simmons HA, Xu G, Li M, Plum L, Clagett-Dame M, DeLuca HF, Thompson DD, Brown TA. A new vitamin D analog, 2MD, restores trabecular and cortical bone mass and strength in ovariectomized rats with established osteopenia. J Bone Miner Res. 2005 Oct;20(10):1742-55. doi: 10.1359/JBMR.050605. Epub 2005 Jun 13.
• Plum LA, Fitzpatrick LA, Ma X, Binkley NC, Zella JB, Clagett-Dame M, DeLuca HF. 2MD, a new anabolic agent for osteoporosis treatment. Osteoporos Int. 2006;17(5):704-15. doi: 10.1007/s00198-005-0036-3. Epub 2006 Feb 21.
• Shevde NK, Plum LA, Clagett-Dame M, Yamamoto H, Pike JW, DeLuca HF. A potent analog of 1alpha,25-dihydroxyvitamin D3 selectively induces bone formation. Proc Natl Acad Sci U S A. 2002 Oct 15;99(21):13487-91. doi: 10.1073/pnas.202471299. Epub 2002 Oct 8.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: July 14, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): January 11, 2010
• Last Update Submitted That Met QC Criteria: December 7, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Vitamin D; Osteoporosis; Bone Density Conservation Agents; Bone Regeneration; 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Dihydroxycholecalciferols
• Other Study ID Numbers: Deltanoid 2MD-3H-2B