Trial Outcomes & Findings for A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis (NCT NCT01292187)
NCT ID: NCT01292187
Last Updated: 2014-09-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
129 participants
Primary outcome timeframe
Baseline, Week 54
Results posted on
2014-09-12
Participant Flow
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.
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
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
43
|
|
Overall Study
COMPLETED
|
69
|
30
|
|
Overall Study
NOT COMPLETED
|
17
|
13
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
5
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
All other reasons
|
1
|
3
|
Baseline Characteristics
A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
rsCT Tablets
n=86 Participants
Patients who received oral calcitonin as an active treatment
|
Placebo Tablets
n=43 Participants
Patients who did not receive any active treatment, just placebo
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 6.90 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 5.16 • n=7 Participants
|
67.2 years
STANDARD_DEVIATION 6.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=5 Participants
|
43 participants
n=7 Participants
|
129 participants
n=5 Participants
|
|
T-score
|
-1.15 T-score
STANDARD_DEVIATION 0.881 • n=5 Participants
|
-1.12 T-score
STANDARD_DEVIATION 0.864 • n=7 Participants
|
-1.14 T-score
STANDARD_DEVIATION 0.872 • n=5 Participants
|
|
FRAX Score
|
11.87 percent probability
STANDARD_DEVIATION 5.019 • n=5 Participants
|
11.57 percent probability
STANDARD_DEVIATION 4.468 • n=7 Participants
|
11.77 percent probability
STANDARD_DEVIATION 4.827 • n=5 Participants
|
|
LS BMD
|
0.940 grams per square centimeter
STANDARD_DEVIATION 0.106 • n=5 Participants
|
0.929 grams per square centimeter
STANDARD_DEVIATION 0.907 • n=7 Participants
|
0.936 grams per square centimeter
STANDARD_DEVIATION 0.102 • n=5 Participants
|
|
Body Mass Index
|
25.81 kg/m^2
STANDARD_DEVIATION 3.765 • n=5 Participants
|
26.77 kg/m^2
STANDARD_DEVIATION 5.983 • n=7 Participants
|
26.13 kg/m^2
STANDARD_DEVIATION 25.48 • n=5 Participants
|
|
CTx-1
|
423.95 ng/L
STANDARD_DEVIATION 219.419 • n=5 Participants
|
417 ng/L
STANDARD_DEVIATION 119.882 • n=7 Participants
|
421.74 ng/L
STANDARD_DEVIATION 193.638 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 54Population: MITT population
Outcome measures
| Measure |
Oral Calcitonin Tablets
n=74 Participants
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
n=35 Participants
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.
|
|---|---|---|
|
Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.
|
1.03 percent change
Interval 0.46 to 1.59
|
-0.12 percent change
Interval -0.94 to 0.71
|
SECONDARY outcome
Timeframe: Baseline, Week 54Population: MITT population
Outcome measures
| Measure |
Oral Calcitonin Tablets
n=78 Participants
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
n=36 Participants
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.
|
|---|---|---|
|
Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.
|
-11.83 percent change
Interval -22.43 to -1.43
|
8.37 percent change
Interval -7.11 to 23.85
|
Adverse Events
Oral rsCT Tablets
Serious events: 6 serious events
Other events: 33 other events
Deaths: 0 deaths
Oral Placebo Tablets
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral rsCT Tablets
n=86 participants at risk
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
n=43 participants at risk
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.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified
|
3.5%
3/86 • Number of events 3 • 1 year
|
4.7%
2/43 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.3%
2/86 • Number of events 3 • 1 year
|
0.00%
0/43 • 1 year
|
|
Hepatobiliary disorders
Hepatitis acute
|
1.2%
1/86 • Number of events 1 • 1 year
|
0.00%
0/43 • 1 year
|
|
Cardiac disorders
Pericardial effusions
|
1.2%
1/86 • Number of events 1 • 1 year
|
0.00%
0/43 • 1 year
|
|
Infections and infestations
Sepsis
|
1.2%
1/86 • Number of events 1 • 1 year
|
0.00%
0/43 • 1 year
|
|
General disorders
Pyrexia
|
1.2%
1/86 • Number of events 1 • 1 year
|
0.00%
0/43 • 1 year
|
Other adverse events
| Measure |
Oral rsCT Tablets
n=86 participants at risk
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
n=43 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.0%
6/86 • Number of events 9 • 1 year
|
14.0%
6/43 • Number of events 9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
9.3%
8/86 • Number of events 10 • 1 year
|
16.3%
7/43 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.5%
9/86 • Number of events 11 • 1 year
|
2.3%
1/43 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.6%
10/86 • Number of events 11 • 1 year
|
2.3%
1/43 • Number of events 1 • 1 year
|
Additional Information
Dr. David Krause, Chief Medical Officer
Tarsa Therapeutics, Inc.
Phone: 1-267-273-7940
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place