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
Results First Received: September 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Placebo
Drug: DP001

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled from 5 March 2007 to 19 December 2007 at 9 centers within the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo soft gel capsules, oral, once daily
220 ng of Vitamin D Analog (DP001) 220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3.
440 ng DP001 440 ng DP001 soft gel capsules, oral, once daily

Participant Flow:   Overall Study
    Placebo     220 ng of Vitamin D Analog (DP001)     440 ng DP001  
STARTED     49 [1]   54     53  
COMPLETED     43     43     21  
NOT COMPLETED     6     11     32  
Adverse Event                 3                 5                 21  
Withdrawal by Subject                 1                 3                 8  
Lost to Follow-up                 1                 2                 1  
Terminated by Sponsor                 1                 0                 0  
Did Not Meet Entry Criteria                 0                 0                 1  
Use of Exclusionary Medication                 0                 0                 1  
Elevated Blood Glucose                 0                 1                 0  
[1] 1 additional subject was enrolled in the placebo group but discontinued before taking any study drug



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo soft gel capsules, oral, once daily
220 ng DP001 220 ng DP001 soft gel capsules, oral, once daily
440 ng DP001 440 ng DP001 soft gel capsules, oral, once daily
Total Total of all reporting groups

Baseline Measures
    Placebo     220 ng DP001     440 ng DP001     Total  
Number of Participants  
[units: participants]
  49     54     53     156  
Age  
[units: years]
Mean ± Standard Deviation
  61.1  ± 6.5     61.6  ± 5.5     61.9  ± 5.3     61.5  ± 5.8  
Gender  
[units: participants]
       
Female     49     54     53     156  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52   [ Time Frame: Baseline and Week 52 ]

2.  Secondary:   Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52   [ Time Frame: Baseline and Week 52 ]

3.  Secondary:   Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52   [ Time Frame: Baseline and Week 52 ]

4.  Secondary:   Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52   [ Time Frame: Baseline and Week 52 ]

5.  Secondary:   Change From Baseline in Serum Calcium Levels at Week 52   [ Time Frame: Baseline and Week 52 ]

6.  Secondary:   Percent Change From Baseline in Serum Bone Markers at Week 26   [ Time Frame: Baseline and Week 26 ]

7.  Secondary:   Number of Subjects With at Least 1 Treatment-emergent Adverse Event   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Hector F. DeLuca, President and Chief Executive Officer
Organization: Deltanoid Pharmaceuticals
phone: 608-238-7710
e-mail: info@deltanoid.com


Publications:

Responsible Party: Hector F. DeLuca, President and Chief Executive Officer, Deltanoid Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00715676     History of Changes
Other Study ID Numbers: Deltanoid 2MD-3H-2B
Study First Received: July 14, 2008
Results First Received: September 16, 2009
Last Updated: December 7, 2009
Health Authority: United States: Food and Drug Administration