Skip to main content
OpenTrials
Completed

NCT Number: NCT00715676

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Boling Clinical Trials, Upland, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

oral, once daily

DP001

Drug

oral, once daily

Other names: 2-methylene-19-nor-(20S)-1a, 25-dihydroxyvitamin D3, 2MD

Primary outcomes

  1. Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52

    Time frame: Baseline and Week 52

    Percent change in lumbar spine BMD (relative to baseline) at Week 52

Secondary outcomes

  1. Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52

    Time frame: Baseline and Week 52

    The percent change in hip BMD (relative to baseline) at Week 52

  2. Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52

    Time frame: Baseline and Week 52

    Percent change in femoral neck BMD (relative to baseline) at Week 52

  3. Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52

    Time frame: Baseline and Week 52

    Percent change in trochanter BMD (relative to baseline) at Week 52

  4. Change From Baseline in Serum Calcium Levels at Week 52

    Time frame: Baseline and Week 52

    Change in serum calcium value (relative to baseline) at Week 52

  5. Percent Change From Baseline in Serum Bone Markers at Week 26

    Time frame: Baseline and Week 26

    Percent change from baseline at Week 26

  6. Number of Subjects With at Least 1 Treatment-emergent Adverse Event

    Time frame: 1 year

    To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.

Sponsors and collaborators

Lead sponsor

Deltanoid Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: 2MD-3H-2B

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jul 15, 2008
Registry last updated
Jan 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.