Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
NCT ID: NCT00715676
Last Updated: 2010-01-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
157 participants
INTERVENTIONAL
2007-03-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Placebo
oral, once daily
Group 2
220 ng
DP001
oral, once daily
Group 3
440 ng
DP001
oral, once daily
Interventions
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Placebo
oral, once daily
DP001
oral, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index of 18 to 35
* Osteopenic
* Generally healthy
* Informed consent
Exclusion Criteria
* 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
55 Years
80 Years
FEMALE
No
Sponsors
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Deltanoid Pharmaceuticals
INDUSTRY
Responsible Party
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Deltanoid Pharmaceuticals
Principal Investigators
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Wendy A Bedale, Ph.D.
Role: STUDY_DIRECTOR
Deltanoid Pharmaceuticals
Locations
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Boling Clinical Trials
Upland, California, United States
Indiana School of Medicine University Hospital
Indianapolis, Indiana, United States
Bethesda Health Research
Bethesda, Maryland, United States
Creighton University Bone Metabolism Unit
Omaha, Nebraska, United States
New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, United States
Winthrop University Hospital Bone Mineral Research Center
Mineola, New York, United States
Helen Hayes Hospital Clinical Research Center
West Haverstraw, New York, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
University of Wisconsin-Madison Osteoporosis Clinical Research
Madison, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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Deltanoid 2MD-3H-2B
Identifier Type: -
Identifier Source: org_study_id
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