A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women (ORACAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00959764
First received: August 14, 2009
Last updated: September 16, 2013
Last verified: September 2013
Results First Received: October 26, 2012  
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, Postmenopausal
Interventions: Drug: Oral Calcitonin Tablets
Drug: Intranasal Calcitonin
Drug: Placebo tablets and placebo intranasal spray

  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
Patients were recruited from clinics in the USA,UK,Poland, Bulgaria, Hungary, and Republic of South Africa.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Unequal randomization was used for the study, with patients being assigned after inclusion/exclusion criteria were met.

Reporting Groups
  Description
Oral Calcitonin Patients who only received oral calcitonin as an active treatment
Nasal Calcitonin Patients who only received nasal calcitonin as active treatment
Placebo Patients who did not receive any active treatment

Participant Flow:   Overall Study
    Oral Calcitonin     Nasal Calcitonin     Placebo  
STARTED     271     185     109  
COMPLETED     176     128     73  
NOT COMPLETED     95     57     36  



  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.
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Reporting Groups
  Description
Oral Calcitonin Patients who only received oral calcitonin as an active treatment
Nasal Calcitonin Patients who only received nasal calcitonin as active treatment
Placebo Patients who did not receive any active treatment
Total Total of all reporting groups

Baseline Measures
    Oral Calcitonin     Nasal Calcitonin     Placebo     Total  
Number of Participants  
[units: participants]
  271     185     109     565  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     115     77     39     231  
>=65 years     156     108     70     334  
Age  
[units: years]
Mean ± Standard Deviation
  66.5  ± 7.6     66.4  ± 7.0     66.5  ± 8.0     66.5  ± 7.5  
Gender  
[units: participants]
       
Female     271     185     109     565  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     35     24     12     71  
Hungary     29     16     9     54  
Poland     59     45     33     137  
South Africa     52     33     14     99  
Bulgaria     21     15     9     45  
United Kingdom     75     52     32     159  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine   [ Time Frame: 48 weeks ]

2.  Secondary:   Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)   [ Time Frame: 24 weeks ]

3.  Secondary:   Change in Plasma CTx-1 From Baseline   [ Time Frame: 48 weeks ]


  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 NOT 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.


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
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Results Point of Contact:  
Name/Title: Dr. David Krause, Chief Medical Officer
Organization: Tarsa Theapeutics, Inc.
phone: 1-267-273-7940
e-mail: dkrause@tarsatherapeutics.com


Publications of Results:

Responsible Party: Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00959764     History of Changes
Other Study ID Numbers: UGL-OR0801, 2008-003322-42
Study First Received: August 14, 2009
Results First Received: October 26, 2012
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration