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

Osteoporosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715676
• Other study ID #: Deltanoid 2MD-3H-2B
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2008
• Last updated: December 7, 2009
• Start date: March 2007
• Est. completion date: January 2009

Study information

• Verified date: December 2009
• Source: Deltanoid Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Placebo
oral, once daily
• DP001
oral, once daily

Locations

Country	Name	City	State
United States	New Mexico Clinical Research and Osteoporosis Center	Albuquerque	New Mexico
United States	Bethesda Health Research	Bethesda	Maryland
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Indiana School of Medicine University Hospital	Indianapolis	Indiana
United States	University of Wisconsin-Madison Osteoporosis Clinical Research	Madison	Wisconsin
United States	Winthrop University Hospital Bone Mineral Research Center	Mineola	New York
United States	Creighton University Bone Metabolism Unit	Omaha	Nebraska
United States	Boling Clinical Trials	Upland	California
United States	Helen Hayes Hospital Clinical Research Center	West Haverstraw	New York

Sponsors (1)

Lead Sponsor	Collaborator
Deltanoid Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & 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. Epub 2005 Jun 13. — View 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. Epub 2006 Feb 21. — View 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. Epub 2002 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52		Baseline and Week 52	No
Secondary	Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52		Baseline and Week 52	No
Secondary	Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52		Baseline and Week 52	No
Secondary	Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52		Baseline and Week 52	No
Secondary	Change From Baseline in Serum Calcium Levels at Week 52		Baseline and Week 52	Yes
Secondary	Percent Change From Baseline in Serum Bone Markers at Week 26		Baseline and Week 26	No
Secondary	Number of Subjects With at Least 1 Treatment-emergent Adverse Event		1 year	Yes