Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Deltanoid Pharmaceuticals

Conditions:

Osteoporosis

Eligibility:

FEMALE

55-80 years

Phase:

PHASE2

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 tolera...

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,...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2009

    Estimated Enrollment :

    157 Patients enrolled

    Trial Details

    Trial ID

    NCT00715676

    Start Date

    March 1 2007

    End Date

    January 1 2009

    Last Update

    January 11 2010

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Boling Clinical Trials

    Upland, California, United States, 91786

    2

    Indiana School of Medicine University Hospital

    Indianapolis, Indiana, United States, 46202

    3

    Bethesda Health Research

    Bethesda, Maryland, United States, 20817

    4

    Creighton University Bone Metabolism Unit

    Omaha, Nebraska, United States, 68131