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

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ClinicalTrials.gov Identifier: NCT01292187
Recruitment Status : Completed
First Posted : February 9, 2011
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Tarsa Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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
Enrollment 129
Recruitment Details

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 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
Arm/Group Title Oral rsCT Tablets Oral Placebo Tablets
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 86 43
Completed 69 30
Not Completed 17 13
Reason Not Completed
Adverse Event             10             5
Withdrawal by Subject             6             5
All other reasons             1             3
Arm/Group Title rsCT Tablets Placebo Tablets Total
Hide Arm/Group Description Patients who received oral calcitonin as an active treatment Patients who did not receive any active treatment, just placebo Total of all reporting groups
Overall Number of Baseline Participants 86 43 129
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 43 participants 129 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  32.6%
14
  32.6%
42
  32.6%
>=65 years
58
  67.4%
29
  67.4%
87
  67.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 43 participants 129 participants
67.5  (6.90) 66.6  (5.16) 67.2  (6.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 43 participants 129 participants
Female
86
 100.0%
43
 100.0%
129
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 43 participants 129 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.3%
0
   0.0%
2
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   2.3%
2
   4.7%
4
   3.1%
White
81
  94.2%
41
  95.3%
122
  94.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.2%
0
   0.0%
1
   0.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 86 participants 43 participants 129 participants
86 43 129
T-score   [1] 
Mean (Standard Deviation)
Unit of measure:  T-score
Number Analyzed 86 participants 43 participants 129 participants
-1.15  (0.881) -1.12  (0.864) -1.14  (0.872)
[1]
Measure Description: 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].
FRAX Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent probability
Number Analyzed 86 participants 43 participants 129 participants
11.87  (5.019) 11.57  (4.468) 11.77  (4.827)
[1]
Measure Description: 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.
LS BMD   [1] 
Mean (Standard Deviation)
Unit of measure:  Grams per square centimeter
Number Analyzed 86 participants 43 participants 129 participants
0.940  (0.106) 0.929  (0.907) 0.936  (0.102)
[1]
Measure Description: 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.
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 86 participants 43 participants 129 participants
25.81  (3.765) 26.77  (5.983) 26.13  (25.48)
CTx-1   [1] 
Mean (Standard Deviation)
Unit of measure:  ng/L
Number Analyzed 86 participants 43 participants 129 participants
423.95  (219.419) 417  (119.882) 421.74  (193.638)
[1]
Measure Description: C-terminal telopeptide-1
1.Primary Outcome
Title Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.
Hide Description [Not Specified]
Time Frame Baseline, Week 54
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Oral Calcitonin Tablets Oral Placebo Tablets
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 74 35
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
1.03
(0.46 to 1.59)
-0.12
(-0.94 to 0.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Calcitonin Tablets, Oral Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0265
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.
Hide Description [Not Specified]
Time Frame Baseline, Week 54
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
MITT population
Arm/Group Title Oral rsCT Tablets Oral Placebo Tablets
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 78 36
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-11.83
(-22.43 to -1.43)
8.37
(-7.11 to 23.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral rsCT Tablets, Oral Placebo Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0340
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral rsCT Tablets Oral Placebo Tablets
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Oral rsCT Tablets Oral Placebo Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oral rsCT Tablets Oral Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/86 (6.98%)      2/43 (4.65%)    
Cardiac disorders     
Pericardial effusions  1  1/86 (1.16%)  1 0/43 (0.00%)  0
General disorders     
Pyrexia  1 [1]  1/86 (1.16%)  1 0/43 (0.00%)  0
Hepatobiliary disorders     
Hepatitis acute  1 [2]  1/86 (1.16%)  1 0/43 (0.00%)  0
Infections and infestations     
Sepsis  1  1/86 (1.16%)  1 0/43 (0.00%)  0
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications  1 [3]  2/86 (2.33%)  3 0/43 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified  1 [4]  3/86 (3.49%)  3 2/43 (4.65%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Intermittent Fever
[2]
Acute Hepatitis
[3]
Laceration/ Cranial Laceration
[4]
Malignant melanoma/ Melanoma On Left Eyelid
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral rsCT Tablets Oral Placebo Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/86 (38.37%)      15/43 (34.88%)    
Gastrointestinal disorders     
Abdominal pain  1  6/86 (6.98%)  9 6/43 (13.95%)  9
Abdominal discomfort  1  9/86 (10.47%)  11 1/43 (2.33%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  10/86 (11.63%)  11 1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  1  8/86 (9.30%)  10 7/43 (16.28%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
Responsible Party: Tarsa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01292187     History of Changes
Other Study ID Numbers: TAR-01-201
First Submitted: February 7, 2011
First Posted: February 9, 2011
Results First Submitted: July 11, 2013
Results First Posted: September 12, 2014
Last Update Posted: September 12, 2014