A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01292187
First received: February 7, 2011
Last updated: September 5, 2014
Last verified: September 2014
Results First Received: July 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Osteopenia
Interventions: Drug: Oral calcitonin at dinnertime
Drug: Oral placebo at dinnertime
Drug: Oral calcitonin at bedtime
Drug: Oral placebo at bedtime

  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 will be recruited from outpatient populations associated with health care centers that treat osteoporosis. Community advertising may also be used for those not associated with such centers.

Recruitment began on 17 January 2011.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients had a two-week single-blind oral placebo (at bedtime) run-in period before group assignment. This was to accustom the patients to the oral dose regimen prior to randomization

Reporting Groups
  Description
Oral rsCT Tablets Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
Oral Placebo Tablets Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.

Participant Flow:   Overall Study
    Oral rsCT Tablets     Oral Placebo Tablets  
STARTED     86     43  
COMPLETED     69     30  
NOT COMPLETED     17     13  
Adverse Event                 10                 5  
Withdrawal by Subject                 6                 5  
All other reasons                 1                 3  



  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.
Baseline Lumbar Spine BMD (Bone Mineral Density) T-scores, plasma CTx-1 (collagen type 1 C telopeptide), , FRAX scores, age, race and body weight were compared between the two treatment arms and were found to have similar means, respectively.

Reporting Groups
  Description
rsCT Tablets Patients who received oral calcitonin as an active treatment
Placebo Tablets Patients who did not receive any active treatment, just placebo
Total Total of all reporting groups

Baseline Measures
    rsCT Tablets     Placebo Tablets     Total  
Number of Participants  
[units: participants]
  86     43     129  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     14     42  
>=65 years     58     29     87  
Age  
[units: years]
Mean ± Standard Deviation
  67.5  ± 6.90     66.6  ± 5.16     67.2  ± 6.37  
Gender  
[units: participants]
     
Female     86     43     129  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     2     0     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     2     4  
White     81     41     122  
More than one race     0     0     0  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     86     43     129  
T-score [1]
[units: T-score]
Mean ± Standard Deviation
  -1.15  ± 0.881     -1.12  ± 0.864     -1.14  ± 0.872  
FRAX Score [2]
[units: percent probability]
Mean ± Standard Deviation
  11.87  ± 5.019     11.57  ± 4.468     11.77  ± 4.827  
LS BMD [3]
[units: grams per square centimeter]
Mean ± Standard Deviation
  0.940  ± 0.106     0.929  ± 0.907     0.936  ± 0.102  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  25.81  ± 3.765     26.77  ± 5.983     26.13  ± 25.48  
CTx-1 [4]
[units: ng/L]
Mean ± Standard Deviation
  423.95  ± 219.419     417  ± 119.882     421.74  ± 193.638  
[1] The National Osteoporosis Foundation suggested that women with osteopenia (T-score between -1.0 and -2.5 Standard Deviations from the BMD mean value of healthy 30-year old women) and additional risk factors should be treated. For entry into this study, the recommendations of the US Preventative Services Task Force (USPSTF) have been adapted, such that subjects with osteopenia (BMD and a 10-year fracture risk at least that of an average risk 65-year-old woman) were included (World Health Organization’s Fracture Risk Assessment Tool (FRAX®) [USPSTF, 2010].
[2] FRAX® is a computer based algorithm (http://www.shef.ac.uk/FRAX) that provides models for the assessment of fracture probability in men and women. The approach uses easily obtained clinical risk factors to estimate 10 year fracture probability for a major fracture due to osteoporosis. Major fracture means a clinically apparent fracture of the hip, spine, humerus (upper arm) or wrist.
[3] LS BMD was determined at baseline with Dual Energy X-ray Absorptionometry (DEXA) scans and expressed as grams/square centimeter. This was used to calculate T-scores and used as the baseline to assess changes.
[4] C-terminal telopeptide-1



  Outcome Measures
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1.  Primary:   Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.   [ Time Frame: Baseline, Week 54 ]

2.  Secondary:   Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.   [ Time Frame: Baseline, Week 54 ]


  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 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.


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


No publications provided


Responsible Party: Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01292187     History of Changes
Other Study ID Numbers: TAR-01-201
Study First Received: February 7, 2011
Results First Received: July 11, 2013
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration