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

This study has been completed.
Sponsor:
Information provided by:
Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00715676
First received: July 14, 2008
Last updated: December 7, 2009
Last verified: December 2009

July 14, 2008
December 7, 2009
March 2007
December 2008   (final data collection date for primary outcome measure)
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Lumbar spine BMD [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00715676 on ClinicalTrials.gov Archive Site
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  • Change From Baseline in Serum Calcium Levels at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
  • Percent Change From Baseline in Serum Bone Markers at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects With at Least 1 Treatment-emergent Adverse Event [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • BMD response at additional non-spinal sites [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum calcium levels [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Bone marker levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoporosis
  • Drug: Placebo
    oral, once daily
  • Drug: DP001
    oral, once daily
    Other Names:
    • 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3
    • 2MD
  • Placebo Comparator: Group 1
    Intervention: Drug: Placebo
  • Experimental: Group 2
    220 ng
    Intervention: Drug: DP001
  • Experimental: Group 3
    440 ng
    Intervention: Drug: DP001

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
January 2009
December 2008   (final data collection date for primary outcome measure)

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
Female
55 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00715676
Deltanoid 2MD-3H-2B
Yes
Hector F. DeLuca, President and Chief Executive Officer, Deltanoid Pharmaceuticals
Deltanoid Pharmaceuticals
Not Provided
Study Director: Wendy A Bedale, Ph.D. Deltanoid Pharmaceuticals
Deltanoid Pharmaceuticals
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP