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

Overview

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.

Full Title of Study: “A Phase 2, Double-blind, Randomized, Placebo-Controlled, Daily-dose, Proof-of-concept Study of a Vitamin D Compound in Postmenopausal Women With Osteopenia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2008

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, 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.

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: Group 1
  • Experimental: Group 2
    • 220 ng
  • Experimental: Group 3
    • 440 ng

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • Percent Change From Baseline in Serum Bone Markers at Week 26
    • Time Frame: Baseline and Week 26
    • Percent change from baseline at Week 26
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 55 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Deltanoid Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Hector F. DeLuca, President and Chief Executive Officer, Deltanoid Pharmaceuticals
  • Overall Official(s)
    • Wendy A Bedale, Ph.D., Study Director, Deltanoid Pharmaceuticals

References

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.

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