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The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

This study has been terminated.
(Slow enrolment)
Sponsor:
Information provided by (Responsible Party):
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00713258
First received: July 2, 2008
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Back Pain
Interventions: Drug: Parathyroid hormone (PTH) (1-84)
Drug: Alendronate

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PTH (1-84)

PTH (1-84) + placebo alendronate

  • PTH (1-84): powder and solvent for solution for injection
  • placebo alendronate: capsule
Alendronate

PTH (1-84) placebo + alendronate

  • PTH (1-84) placebo: powder and solvent for solution for injection
  • alendronate: capsule

Participant Flow:   Overall Study
    PTH (1-84)     Alendronate  
STARTED     41     34  
COMPLETED     36     28  
NOT COMPLETED     5     6  
Adverse Event                 2                 4  
Non-Compliance                 2                 1  
Other                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
PTH (1-84)

PTH (1-84) + placebo alendronate

  • PTH (1-84): powder and solvent for solution for injection
  • placebo alendronate: capsule
Alendronate

PTH (1-84) placebo + alendronate

  • PTH (1-84) placebo: powder and solvent for solution for injection
  • alendronate: capsule
Total Total of all reporting groups

Baseline Measures
    PTH (1-84)     Alendronate     Total  
Number of Participants  
[units: participants]
 		  41     34     75  
Age  
[units: years]
Mean ± Standard Deviation 		  70.7  ± 9.14     69.8  ± 7.84     70.3  ± 8.53  
Gender, Customized  
[units: participants]
 		     
Female     41     34     75  
Vertebral Fracture at Baseline [1]
[units: vertebral fractures per patient]
Mean ± Standard Deviation 		  3.44  ± 2.49     2.94  ± 1.97     3.21  ± 2.27  
Family history of osteoporosis [2]
[units: patients]
 		  13     9     22  
Age at onset of menopause  
[units: years]
Mean ± Standard Deviation 		  48.5  ± 3.68     48.6  ± 5.25     48.5  ± 4.43  
Mean NRS score [3]
[units: scores on a scale]
Mean ± Standard Deviation 		  6.60  ± 1.45     6.36  ± 1.70     6.49  ± 1.56  
[1] The baseline measure is shown as average number per patient.
[2] A family history of osteoporosis was reported by 22 subjects, which differs from the overall number of baseline participants.
[3] NRS = 11-point numerical rating scale to assess the pain. The NRS score ranges from 0 to 10, with lower scores meaning less pain.



  Outcome Measures
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1.  Primary:   Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.   [ Time Frame: Baseline and 24 weeks treatment ]
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2.  Secondary:   Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment   [ Time Frame: Baseline and 24 weeks treatment ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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 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
Early termination leading to small number of subjects analyzed.  


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: A Takeda Company
ClinicalTrials.gov Identifier: NCT00713258     History of Changes
Other Study ID Numbers: FP-005-IM
Study First Received: July 2, 2008
Results First Received: July 28, 2011
Last Updated: May 4, 2012
Health Authority: Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios