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

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

DP001

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, Vitamin D, Bone Density Conservation Agents, Bone Regeneration

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Boling Clinical Trials
Indiana School of Medicine University Hospital
Bethesda Health Research
Creighton University Bone Metabolism Unit
New Mexico Clinical Research and Osteoporosis Center
Winthrop University Hospital Bone Mineral Research Center
Helen Hayes Hospital Clinical Research Center
Altoona Center for Clinical Research
University of Wisconsin-Madison Osteoporosis Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

220 ng

440 ng

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52

Percent change in trochanter BMD (relative to baseline) at Week 52

Change From Baseline in Serum Calcium Levels at Week 52

Change in serum calcium value (relative to baseline) at Week 52

Percent Change From Baseline in Serum Bone Markers at Week 26

Percent change from baseline at 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.

Full Information

NCT ID

NCT00715676

First Posted

July 14, 2008

Last Updated

December 7, 2009

Sponsor

Deltanoid Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00715676

Brief Title

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

Acronym

2MD-3H-2B

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Deltanoid Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Osteoporosis, 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, Vitamin D, Bone Density Conservation Agents, Bone Regeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

157 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Placebo Comparator

Arm Title

Group 2

Arm Type

Experimental

Arm Description

220 ng

Arm Title

Group 3

Arm Type

Experimental

Arm Description

440 ng

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral, once daily

Intervention Type

Drug

Intervention Name(s)

DP001

Other Intervention Name(s)

2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, 2MD

Intervention Description

oral, once daily

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52

Description

Percent change in lumbar spine BMD (relative to baseline) at Week 52

Time Frame

Baseline and Week 52

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52

Description

The percent change in hip BMD (relative to baseline) at Week 52

Time Frame

Baseline and Week 52

Title

Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52

Description

Percent change in femoral neck BMD (relative to baseline) at Week 52

Time Frame

Baseline and Week 52

Title

Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52

Description

Percent change in trochanter BMD (relative to baseline) at Week 52

Time Frame

Baseline and Week 52

Title

Change From Baseline in Serum Calcium Levels at Week 52

Description

Change in serum calcium value (relative to baseline) at Week 52

Time Frame

Baseline and Week 52

Title

Percent Change From Baseline in Serum Bone Markers at Week 26

Description

Percent change from baseline at Week 26

Time Frame

Baseline and Week 26

Title

Number of Subjects With at Least 1 Treatment-emergent Adverse Event

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wendy A Bedale, Ph.D.

Organizational Affiliation

Deltanoid Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Boling Clinical Trials

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Indiana School of Medicine University Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Bethesda Health Research

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Creighton University Bone Metabolism Unit

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

New Mexico Clinical Research and Osteoporosis Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Facility Name

Winthrop University Hospital Bone Mineral Research Center

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Helen Hayes Hospital Clinical Research Center

City

West Haverstraw

State/Province

New York

ZIP/Postal Code

10993

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

University of Wisconsin-Madison Osteoporosis Clinical Research

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16160732

Citation

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.

Results Reference

background

PubMed Identifier

16491322

Citation

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.

Results Reference

background

PubMed Identifier

12374862

Citation

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.

Results Reference

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

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