Trial Outcomes & Findings for A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women (NCT NCT00959764)
NCT ID: NCT00959764
Last Updated: 2013-11-19
Results Overview
Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
565 participants
Primary outcome timeframe
48 weeks
Results posted on
2013-11-19
Participant Flow
Patients were recruited from clinics in the USA,UK,Poland, Bulgaria, Hungary, and Republic of South Africa.
Unequal randomization was used for the study, with patients being assigned after inclusion/exclusion criteria were met.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
271
|
185
|
109
|
|
Overall Study
COMPLETED
|
176
|
128
|
73
|
|
Overall Study
NOT COMPLETED
|
95
|
57
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women
Baseline characteristics by cohort
| Measure |
Oral Calcitonin
n=271 Participants
Patients who only received oral calcitonin as an active treatment
|
Nasal Calcitonin
n=185 Participants
Patients who only received nasal calcitonin as active treatment
|
Placebo
n=109 Participants
Patients who did not receive any active treatment
|
Total
n=565 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
115 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
156 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
334 Participants
n=4 Participants
|
|
Age Continuous
|
66.5 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
66.5 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
66.5 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
271 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
565 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
24 participants
n=7 Participants
|
12 participants
n=5 Participants
|
71 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
29 participants
n=5 Participants
|
16 participants
n=7 Participants
|
9 participants
n=5 Participants
|
54 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
59 participants
n=5 Participants
|
45 participants
n=7 Participants
|
33 participants
n=5 Participants
|
137 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
52 participants
n=5 Participants
|
33 participants
n=7 Participants
|
14 participants
n=5 Participants
|
99 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
21 participants
n=5 Participants
|
15 participants
n=7 Participants
|
9 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
75 participants
n=5 Participants
|
52 participants
n=7 Participants
|
32 participants
n=5 Participants
|
159 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Patients who were randomized, received treatment, and had at least one post-baseline BMD value measured at least 154 days after randomization.
Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure.
Outcome measures
| Measure |
Oral Calcitonin
n=189 Participants
Patients who were provided active oral calcitonin and placebo nasal medication in a blinded fashion.
|
Nasal Calcitonin
n=140 Participants
Patients who were provided active nasal calcitonin and placebo oral medication in a blinded fashion.
|
Placebo
n=82 Participants
Patients who were provided nasal and oral placebo medication in a blinded fashion
|
|---|---|---|---|
|
Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine
|
1.53 Percentage increase from baseline
Standard Deviation 3.17 • Interval -7.2 to 12.0
|
0.76 Percentage increase from baseline
Standard Deviation 2.91 • Interval -7.49 to 9.1
|
0.47 Percentage increase from baseline
Standard Deviation 3.21 • Interval -9.78 to 7.84
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Modified Intent-to-Treat Population
Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo.
Outcome measures
| Measure |
Oral Calcitonin
n=184 Participants
Patients who were provided active oral calcitonin and placebo nasal medication in a blinded fashion.
|
Nasal Calcitonin
n=135 Participants
Patients who were provided active nasal calcitonin and placebo oral medication in a blinded fashion.
|
Placebo
n=78 Participants
Patients who were provided nasal and oral placebo medication in a blinded fashion
|
|---|---|---|---|
|
Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)
|
-42.93 percentage change from baseline
Standard Deviation 41.99
|
-24.64 percentage change from baseline
Standard Deviation 41.61
|
-21.09 percentage change from baseline
Standard Deviation 62.46
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Modified Intent-to-Treat Population
Percent change from baseline of plasma CTx-1 at end of study=48 weeks
Outcome measures
| Measure |
Oral Calcitonin
n=188 Participants
Patients who were provided active oral calcitonin and placebo nasal medication in a blinded fashion.
|
Nasal Calcitonin
n=140 Participants
Patients who were provided active nasal calcitonin and placebo oral medication in a blinded fashion.
|
Placebo
n=81 Participants
Patients who were provided nasal and oral placebo medication in a blinded fashion
|
|---|---|---|---|
|
Change in Plasma CTx-1 From Baseline
|
-29.92 Percentage change from baseline
Standard Deviation 47.53
|
-11.41 Percentage change from baseline
Standard Deviation 40.24
|
-11.83 Percentage change from baseline
Standard Deviation 35.58
|
Adverse Events
Oral Calcitonin
Serious events: 20 serious events
Other events: 44 other events
Deaths: 0 deaths
Nasal Calcitonin
Serious events: 9 serious events
Other events: 146 other events
Deaths: 0 deaths
Placebo
Serious events: 9 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Calcitonin
n=263 participants at risk
Patients who only received oral calcitonin as an active treatment
|
Nasal Calcitonin
n=182 participants at risk
Patients who only received nasal calcitonin as active treatment
|
Placebo
n=104 participants at risk
Patients who did not receive any active treatment
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.38%
1/263 • Number of events 1
|
0.55%
1/182 • Number of events 2
|
0.00%
0/104
|
|
Cardiac disorders
Angina unstable
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Cardiac disorders
Cardiac failure congestive
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Eye disorders
Cataract
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/263
|
0.55%
1/182 • Number of events 1
|
0.00%
0/104
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Hepatobiliary disorders
Cholesystitis
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.38%
1/263 • Number of events 1
|
0.55%
1/182 • Number of events 1
|
0.00%
0/104
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.38%
1/263 • Number of events 1
|
0.55%
1/182 • Number of events 1
|
0.00%
0/104
|
|
Injury, poisoning and procedural complications
Facial bone fracture
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/263
|
0.55%
1/182 • Number of events 1
|
0.00%
0/104
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Investigations
Arthroscopy
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/263
|
0.55%
1/182 • Number of events 1
|
0.00%
0/104
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Nervous system disorders
Syncope
|
0.38%
1/263 • Number of events 1
|
0.55%
1/182 • Number of events 1
|
0.00%
0/104
|
|
Nervous system disorders
Ishaemic stroke
|
0.00%
0/263
|
0.55%
1/182 • Number of events 1
|
0.00%
0/104
|
|
Nervous system disorders
Transient ischaemic attack
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Surgical and medical procedures
Hysterectomy
|
0.76%
2/263 • Number of events 2
|
0.00%
0/182
|
0.00%
0/104
|
|
Surgical and medical procedures
Bunion operation
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Surgical and medical procedures
Cataract operation
|
0.38%
1/263 • Number of events 2
|
0.00%
0/182
|
0.00%
0/104
|
|
Surgical and medical procedures
cholecystectomy
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Surgical and medical procedures
Cystocele repair
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Surgical and medical procedures
Skin lesion excision
|
0.38%
1/263 • Number of events 1
|
0.00%
0/182
|
0.00%
0/104
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.00%
0/263
|
0.00%
0/182
|
0.96%
1/104 • Number of events 1
|
|
Surgical and medical procedures
Vaginal operation
|
0.00%
0/263
|
0.55%
1/182 • Number of events 1
|
0.00%
0/104
|
|
Vascular disorders
Hypertensive crisis
|
0.76%
2/263 • Number of events 2
|
0.00%
0/182
|
0.00%
0/104
|
Other adverse events
| Measure |
Oral Calcitonin
n=263 participants at risk
Patients who only received oral calcitonin as an active treatment
|
Nasal Calcitonin
n=182 participants at risk
Patients who only received nasal calcitonin as active treatment
|
Placebo
n=104 participants at risk
Patients who did not receive any active treatment
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
16.7%
44/263 • Number of events 65
|
15.9%
29/182 • Number of events 51
|
14.4%
15/104 • Number of events 23
|
|
Gastrointestinal disorders
abdominal pain upper
|
11.0%
29/263 • Number of events 39
|
9.9%
18/182 • Number of events 28
|
8.7%
9/104 • Number of events 13
|
|
Gastrointestinal disorders
nausea
|
12.2%
32/263 • Number of events 40
|
8.2%
15/182 • Number of events 18
|
6.7%
7/104 • Number of events 11
|
|
Gastrointestinal disorders
constipation
|
6.8%
18/263 • Number of events 20
|
6.6%
12/182 • Number of events 14
|
6.7%
7/104 • Number of events 8
|
|
Gastrointestinal disorders
dyspepsia
|
7.2%
19/263 • Number of events 24
|
4.4%
8/182 • Number of events 8
|
2.9%
3/104 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
17/263 • Number of events 22
|
2.2%
4/182 • Number of events 5
|
6.7%
7/104 • Number of events 8
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
16/263 • Number of events 17
|
8.8%
16/182 • Number of events 16
|
9.6%
10/104 • Number of events 11
|
|
Infections and infestations
Urinary tract Infection
|
5.7%
15/263 • Number of events 18
|
9.3%
17/182 • Number of events 21
|
3.8%
4/104 • Number of events 6
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
11/263 • Number of events 12
|
7.1%
13/182 • Number of events 13
|
7.7%
8/104 • Number of events 8
|
|
Infections and infestations
Influenza
|
6.5%
17/263 • Number of events 17
|
2.7%
5/182 • Number of events 5
|
1.9%
2/104 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
2.3%
6/263 • Number of events 7
|
3.3%
6/182 • Number of events 12
|
5.8%
6/104 • Number of events 6
|
|
Nervous system disorders
Headache
|
7.6%
20/263 • Number of events 25
|
6.0%
11/182 • Number of events 13
|
6.7%
7/104 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
12/263 • Number of events 14
|
7.1%
13/182 • Number of events 15
|
2.9%
3/104 • Number of events 6
|
Additional Information
Dr. David Krause, Chief Medical Officer
Tarsa Theapeutics, Inc.
Phone: 1-267-273-7940
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place