Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00479037
First received: May 23, 2007
Last updated: May 4, 2012
Last verified: May 2012
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Full Length Parathyroid Hormone, PTH(1-84)
Drug: Strontium Ranelate

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
82 subjects were randomized. Of these, one subject was randomized, but consent was withdrawn during the screening period; the subject did not receive any treatment. Therefore, the Intention to treat set (ITT) consisted of 81 subjects.

Reporting Groups
  Description
PTH(1-84) Once daily subcutaneous injection
Strontium Ranelate One sachet (2 g) per day, suspended in water

Participant Flow:   Overall Study
    PTH(1-84)     Strontium Ranelate  
STARTED     41     40  
COMPLETED     38     34  
NOT COMPLETED     3     6  



  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
PTH(1-84) Once daily subcutaneous injection
Strontium Ranelate One sachet (2 g) per day, suspended in water
Total Total of all reporting groups

Baseline Measures
    PTH(1-84)     Strontium Ranelate     Total  
Number of Participants  
[units: participants]
  41     40     81  
Age  
[units: years]
Mean ± Standard Deviation
  64.0  ± 8.64     64.9  ± 8.49     64.4  ± 8.52  
Gender, Customized  
[units: participants]
     
Female     41     40     81  



  Outcome Measures
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1.  Primary:   Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial   [ Time Frame: Baseline and 24 weeks of treatment ]

2.  Primary:   Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial   [ Time Frame: Baseline and 24 weeks of treatment ]

3.  Secondary:   Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial   [ Time Frame: Baseline and 24 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
A limitation of the trial was the open label design, however this is not considered to affect the primary or secondary outcome of the trial.  


Results Point of Contact:  
Name/Title: Clinical Trial Operations
Organization: Nycomed
phone: +45 4677 1111
e-mail: clinicaltrials@nycomed.com


No publications provided


Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00479037     History of Changes
Other Study ID Numbers: FP-006-IM, 2006-006065-16
Study First Received: May 23, 2007
Results First Received: March 31, 2011
Last Updated: May 4, 2012
Health Authority: Austria: Ethikkommission
Spain: Spanish Agency of Medicines