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
1 other identifier
interventional
157
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2007
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
January 11, 2010
CompletedJanuary 11, 2010
December 1, 2009
1.8 years
July 14, 2008
September 16, 2009
December 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52
Baseline and Week 52
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52
Baseline and Week 52
Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52
Baseline and Week 52
Change From Baseline in Serum Calcium Levels at Week 52
Baseline and Week 52
Percent Change From Baseline in Serum Bone Markers at Week 26
Baseline and Week 26
- +1 more secondary outcomes
Study Arms (3)
Group 1
PLACEBO COMPARATORGroup 2
EXPERIMENTAL220 ng
Group 3
EXPERIMENTAL440 ng
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal female subjects, defined as amenorrheic for at least 5 years
- Body Mass Index of 18 to 35
- Osteopenic
- Generally healthy
- Informed consent
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Boling Clinical Trials
Upland, California, 91786, United States
Indiana School of Medicine University Hospital
Indianapolis, Indiana, 46202, United States
Bethesda Health Research
Bethesda, Maryland, 20817, United States
Creighton University Bone Metabolism Unit
Omaha, Nebraska, 68131, United States
New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, 87106, United States
Winthrop University Hospital Bone Mineral Research Center
Mineola, New York, 11501, United States
Helen Hayes Hospital Clinical Research Center
West Haverstraw, New York, 10993, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
University of Wisconsin-Madison Osteoporosis Clinical Research
Madison, Wisconsin, 53705, United States
Related Publications (3)
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.
PMID: 16160732BACKGROUNDPlum 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.
PMID: 16491322BACKGROUNDShevde 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.
PMID: 12374862BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hector F. DeLuca, President and Chief Executive Officer
- Organization
- Deltanoid Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Wendy A Bedale, Ph.D.
Deltanoid Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 14, 2008
First Posted
July 15, 2008
Study Start
March 1, 2007
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
January 11, 2010
Results First Posted
January 11, 2010
Record last verified: 2009-12