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Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00704847
Recruitment Status : Terminated (Male subjects were terminated due to an imbalance in prostate cancer events)
First Posted : June 25, 2008
Results First Posted : September 12, 2012
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nordic Bioscience A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: Oral Salmon Calcitonin
Drug: Oral Salmon Calcitonin (Placebo)
Enrollment 1030
Recruitment Details

Patients were enrolled at 18 centers in 10 countries: 6 centers in the US, 1 center in the UK, 1 center in Spain,1 center in the Czech Republic, 3 centers in Denmark, 1 center in Hong Kong, 2 centers in Poland, 1 center in Romania, 1 center in Belgium and 1 center in Canada.

First patient randomized: 1 Aug 08 Last patient visit: 10 May 2011

Pre-assignment Details  
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description 0.8 mg SMC021 Oral Calcitonin twice daily 1 SMC021 Placebo tablet twice daily
Period Title: Overall Study
Started 521 509
Completed 300 339
Not Completed 221 170
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo Total
Hide Arm/Group Description 0.8 mg SMC021 Oral Calcitonin twice daily 1 SMC021 Placebo tablet twice daily Total of all reporting groups
Overall Number of Baseline Participants 521 509 1030
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 509 participants 1030 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
292
  56.0%
288
  56.6%
580
  56.3%
>=65 years
229
  44.0%
221
  43.4%
450
  43.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 521 participants 509 participants 1030 participants
64.4  (7.0) 64.2  (6.8) 64.3  (6.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 509 participants 1030 participants
Female
321
  61.6%
305
  59.9%
626
  60.8%
Male
200
  38.4%
204
  40.1%
404
  39.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 521 participants 509 participants 1030 participants
United States 26 21 47
Hong Kong 72 72 144
Czech Republic 36 35 71
Canada 11 8 19
Spain 4 2 6
Belgium 7 7 14
Poland 67 66 133
Romania 9 9 18
Denmark 263 264 527
United Kingdom 26 25 51
1.Primary Outcome
Title Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months
Hide Description The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
Time Frame Change from baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description:
0.8 mg SMC021 Oral Calcitonin twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 520 508
Mean (Standard Deviation)
Unit of Measure: mm
-0.32  (0.693) -0.40  (0.768)
2.Primary Outcome
Title Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index
Hide Description WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).
Time Frame Change from baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the ITT analysis.
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description:
0.8 mg SMC021 Oral Calcitonin twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 520 508
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-80.6  (112.22) -87.9  (116.25)
3.Secondary Outcome
Title Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
Hide Description The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX I/creatinine and CTX-II/creatinine. These biomarkers were analysed in order to assess the cartilage and bone turonver ratio to baseline at month 24.
Time Frame From baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for these outcomes were a total of 150 subjects from the intent-to-treat (ITT) population evenly distributed across sites, all with completed baseline as well as all follow-up visits.
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description:
0.8 mg SMC021 Oral Calcitonin twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 69 81
Mean (Standard Deviation)
Unit of Measure: percentage of change
Serum CTX-I (ng/mL) Number Analyzed 68 participants 81 participants
50.6  (83.74) 40.6  (45.52)
Serum Osteocalcin (ng/mL) Number Analyzed 68 participants 81 participants
3.6  (37.42) 3.9  (26.32)
24-h urine CTX-I/creatinine (µg/mmol) Number Analyzed 69 participants 79 participants
9.8  (85.95) 7.2  (44.36)
24-h urine CTX-II/creatinine (ng/mmol) Number Analyzed 69 participants 79 participants
2.6  (63.13) 2.3  (51.07)
4.Secondary Outcome
Title Knee Disease Progression Assessed by MRI
Hide Description Knee cartilage volume and thickness was assessed by MRI in patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site.
Time Frame From baseline to month 12 and month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of patients from the sites in Ballerup (Denmark), Czech Republic and Romania
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description:
0.8 mg SMC021 Oral Calcitonin twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 152 149
Mean (Standard Deviation)
Unit of Measure: percentage of change
Cartilage Volume Month 12 Number Analyzed 115 participants 130 participants
3.4  (9.11) 3.0  (13.16)
Cartilage Volume Month 24 Number Analyzed 103 participants 119 participants
2.6  (10.18) 3.5  (12.73)
Cartilage Thickness Month 12 Number Analyzed 115 participants 130 participants
4.7  (10.64) 4.7  (8.24)
Cartilage Thickness Month 24 Number Analyzed 103 participants 119 participants
4.5  (10.78) 4.1  (8.67)
5.Secondary Outcome
Title Questionnaire to Assess Function and Physical Activity
Hide Description

Function and physical activity were assessed by assessed by WOMAC function sub-score in the signal knee. The criteria for assessment of the functional classification according to the American Rheumatism Association (ARA) were as follows (Hochberg et al 1992):

I. Completely able to perform usual activities of daily living (self-care, vocational and avocational) II. Able to perform usual self-care and vocational activities, but limited in avocational activities.

III. Able to perform usual self-care activities, but limited in vocational and avocational activities.

IV. Limited ability to perform usual self-care activities, vocational and avocational activities.

Self-care activities included dressing, feeding, bathing, grooming, and toileting. Avocational (recreational and/or leisure) and vocational (work, school, homemaking) activities were patient-desired and age- and sex-specific.

Time Frame From baseline to months 1, 6, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description:
0.8 mg SMC021 Oral Calcitonin twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 520 508
Mean (Standard Deviation)
Unit of Measure: percentage of change
Month 1 Number Analyzed 489 participants 495 participants
-4.8  (44.89) -1.9  (131.20)
Month 6 Number Analyzed 437 participants 452 participants
-22.6  (49.03) -17.9  (64.15)
Month 12 Number Analyzed 386 participants 416 participants
-28.0  (53.97) -28.4  (59.79)
Month 24 Number Analyzed 336 participants 370 participants
-30.3  (77.51) -25.1  (143.05)
6.Secondary Outcome
Title Questionnaire to Assess Stiffness in the Signal Knee.
Hide Description

WOMAC's stiffness subscore was used to assess the stiffness in the signal knee. WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of joint stiffness for when performing each daily function listed in the questionnaire. 0 is no stiffness (best), 100 is extreme stiffness (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 200. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less stiffness).

Patients were instructed not to take analgesics for 3 days prior to the WOMAC test.

Time Frame Baseline to month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description:
0.8 mg SMC021 Oral Calcitonin twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 520 508
Mean (Standard Deviation)
Unit of Measure: percentage of change
-26.1  (90.88) -20.3  (179.22)
7.Secondary Outcome
Title Questionnaire to Assess Health-related Quality of Life
Hide Description

Health-related quality of life was assessed by the EQ-5D questionnaire, which is a patient questionnaire for measure of health, developed by the EuroQol Group.The EQ-5D questionnaire was administered to patients in order to measure change in health-related quality of life (HRQoL) over 2 years.

The subjects marks on a VAS scale from 0 to 100 the number that best describes their health today (0 is worst imaginable health state and 100 is best imaginable health state).

The change from baseline in the EQ-5D VAS was calculated.

Time Frame From baseline to month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description:
0.8 mg SMC021 Oral Calcitonin twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 515 504
Mean (Standard Deviation)
Unit of Measure: percentage of change
13.70  (38.763) 11.82  (40.645)
8.Secondary Outcome
Title Questionnaire to Assess Pain
Hide Description Pain was assessed by the WOMAC subscore in the signal knee by visit. Patients assessed their current pain level using a 100 mm visual analogue scales (VAS) by placing an X on the line that best describes his/her pain, where 0 equaled “No Pain” and 100 equaled “Worst Pain Imaginable”. Patients were instructed not to take analgesics for 3 days prior to the VAS.
Time Frame Baseline, month 1, month 6, month 12, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analysed for this outcome is the intent-to-treat (ITT) population. ITT is the number of randomized subjects who received at least one dose of study medication.
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description:
0.8 mg SMC021 Oral Calcitonin twice daily
1 SMC021 Placebo tablet twice daily
Overall Number of Participants Analyzed 520 508
Mean (Standard Deviation)
Unit of Measure: percentage of change
Month 1 Number Analyzed 489 participants 495 participants
-6.7  (49.50) -9.1  (45.26)
Month 6 Number Analyzed 438 participants 452 participants
-26.9  (51.73) -26.9  (50.43)
Month 12 Number Analyzed 386 participants 416 participants
-31.0  (68.05) -34.6  (61.30)
Month 24 Number Analyzed 336 participants 370 participants
-35.1  (91.63) -37.1  (77.55)
Time Frame From baseline to 30 days following the end of participation
Adverse Event Reporting Description The safety population is all patients randomized who received at least one dose of study medication. There were 2 patients in the randomized population who did not receive any study drug and where therefore excluded from the safety analysis.
 
Arm/Group Title SMC021 Oral Calcitonin SMC021 Placebo
Hide Arm/Group Description 0.8 mg SMC021 Oral Calcitonin twice daily 1 SMC021 Placebo tablet twice daily
All-Cause Mortality
SMC021 Oral Calcitonin SMC021 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SMC021 Oral Calcitonin SMC021 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   77/520 (14.81%)   80/508 (15.75%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/520 (0.00%)  1/508 (0.20%) 
Splenomegaly * 1  0/520 (0.00%)  1/508 (0.20%) 
Cardiac disorders     
Atrial fibrillation * 1  2/520 (0.38%)  3/508 (0.59%) 
Angina pectoris * 1  3/520 (0.58%)  0/508 (0.00%) 
Acute myocardial infarction * 1  2/520 (0.38%)  0/508 (0.00%) 
Myocardial infarction * 1  0/520 (0.00%)  2/508 (0.39%) 
Myocardial ischaemia * 1  1/520 (0.19%)  1/508 (0.20%) 
Acute coronary syndrome * 1  1/520 (0.19%)  0/508 (0.00%) 
Arrhythmia * 1  0/520 (0.00%)  1/508 (0.20%) 
Atrioventricular block * 1  0/520 (0.00%)  1/508 (0.20%) 
Cardiac arrest * 1  1/520 (0.19%)  0/508 (0.00%) 
Coronary artery disease * 1  0/520 (0.00%)  1/508 (0.20%) 
Coronary artery thrombosis * 1  0/520 (0.00%)  1/508 (0.20%) 
Sinus arrhythmia * 1  0/520 (0.00%)  1/508 (0.20%) 
Supraventricular tachycardia * 1  1/520 (0.19%)  0/508 (0.00%) 
Ear and labyrinth disorders     
Middle ear inflammation * 1  1/520 (0.19%)  0/508 (0.00%) 
Endocrine disorders     
Goitre * 1  1/520 (0.19%)  1/508 (0.20%) 
Hyperparathyrodism * 1  0/520 (0.00%)  1/508 (0.20%) 
Eye disorders     
Optic ischaemic neuropathy * 1  0/520 (0.00%)  1/508 (0.20%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/520 (0.19%)  1/508 (0.20%) 
Gastritis * 1  2/520 (0.38%)  0/508 (0.00%) 
Pancreatitis acute * 1  0/520 (0.00%)  2/508 (0.39%) 
Abdominal hernia * 1  0/520 (0.00%)  1/508 (0.20%) 
Abdominal pain upper * 1  0/520 (0.00%)  1/508 (0.20%) 
Crohn´s disease * 1  0/520 (0.00%)  1/508 (0.20%) 
Diverticulum intestinal * 1  0/520 (0.00%)  1/508 (0.20%) 
Gastrointestinal inflammation * 1  0/520 (0.00%)  1/508 (0.20%) 
Haemorrhoids * 1  1/520 (0.19%)  0/508 (0.00%) 
Intestinal obstruction * 1  1/520 (0.19%)  0/508 (0.00%) 
Pancreatitis * 1  1/520 (0.19%)  0/508 (0.00%) 
General disorders     
Chest pain * 1  1/520 (0.19%)  1/508 (0.20%) 
Foreign body reaction * 1  1/520 (0.19%)  0/508 (0.00%) 
Pyrexia * 1  0/520 (0.00%)  1/508 (0.20%) 
Hepatobiliary disorders     
Cholelithiasis * 1  2/520 (0.38%)  1/508 (0.20%) 
Cholangitis acute * 1  1/520 (0.19%)  1/508 (0.20%) 
Cholecystitis * 1  1/520 (0.19%)  0/508 (0.00%) 
Jaundice * 1  1/520 (0.19%)  0/508 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  0/520 (0.00%)  2/508 (0.39%) 
Infections and infestations     
Bronchitis * 1  0/520 (0.00%)  2/508 (0.39%) 
Cellulitis * 1  1/520 (0.19%)  1/508 (0.20%) 
Pneumonia * 1  0/520 (0.00%)  2/508 (0.39%) 
Urinary tract infection * 1  1/520 (0.19%)  1/508 (0.20%) 
Diverticulitis * 1  1/520 (0.19%)  0/508 (0.00%) 
Gastroenteritis * 1  0/520 (0.00%)  1/508 (0.20%) 
Infection * 1  1/520 (0.19%)  0/508 (0.00%) 
Orchitis * 1  0/520 (0.00%)  1/508 (0.20%) 
Pancreatic abscess * 1  0/520 (0.00%)  1/508 (0.20%) 
Sinusitis * 1  0/520 (0.00%)  1/508 (0.20%) 
Injury, poisoning and procedural complications     
Wrist fracture * 1  1/520 (0.19%)  2/508 (0.39%) 
Ankle fracture * 1  1/520 (0.19%)  1/508 (0.20%) 
Femur fracture * 1  2/520 (0.38%)  0/508 (0.00%) 
Radius fracture * 1  0/520 (0.00%)  2/508 (0.39%) 
Tibia fracture * 1  1/520 (0.19%)  1/508 (0.20%) 
Abdominal injury * 1  0/520 (0.00%)  1/508 (0.20%) 
Chemical peritonitis * 1  0/520 (0.00%)  1/508 (0.20%) 
Contusion * 1  0/520 (0.00%)  1/508 (0.20%) 
Cystitis radiation * 1  1/520 (0.19%)  0/508 (0.00%) 
Hip fracture * 1  1/520 (0.19%)  0/508 (0.00%) 
Joint dislocation * 1  1/520 (0.19%)  0/508 (0.00%) 
Ligament rupture * 1  0/520 (0.00%)  1/508 (0.20%) 
Multiple fractures * 1  1/520 (0.19%)  0/508 (0.00%) 
Open wound * 1  1/520 (0.19%)  0/508 (0.00%) 
Overdose * 1  1/520 (0.19%)  0/508 (0.00%) 
Patella fracture * 1  0/520 (0.00%)  1/508 (0.20%) 
Postoperative hernia * 1  0/520 (0.00%)  1/508 (0.20%) 
Upper limb fracture * 1  0/520 (0.00%)  1/508 (0.20%) 
Investigations     
Prostatic specific antigen increased * 1  2/520 (0.38%)  3/508 (0.59%) 
Metabolism and nutrition disorders     
Hypernatraemia * 1  1/520 (0.19%)  0/508 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  6/520 (1.15%)  6/508 (1.18%) 
Osteoarthritis * 1  4/520 (0.77%)  8/508 (1.57%) 
Spinal column stenosis * 1  3/520 (0.58%)  1/508 (0.20%) 
Back pain * 1  1/520 (0.19%)  1/508 (0.20%) 
Intervertebral disc protrusion * 1  1/520 (0.19%)  1/508 (0.20%) 
Arthritis reactive * 1  1/520 (0.19%)  0/508 (0.00%) 
Cervical spinal stenosis * 1  0/520 (0.00%)  1/508 (0.20%) 
Foot deformity * 1  1/520 (0.19%)  0/508 (0.00%) 
Musculoskeletal chest pain * 1  0/520 (0.00%)  1/508 (0.20%) 
Osteonecrosis * 1  0/520 (0.00%)  1/508 (0.20%) 
Spinal osteoarthritis * 1  0/520 (0.00%)  1/508 (0.20%) 
Tendonitis * 1  1/520 (0.19%)  0/508 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer * 1  5/520 (0.96%)  5/508 (0.98%) 
Bladder cancer * 1  3/520 (0.58%)  0/508 (0.00%) 
Abdominal neoplasm * 1  1/520 (0.19%)  0/508 (0.00%) 
Breast cancer * 1  0/520 (0.00%)  1/508 (0.20%) 
Breast cancer metastatic * 1  1/520 (0.19%)  0/508 (0.00%) 
Colon cancer * 1  1/520 (0.19%)  0/508 (0.00%) 
Lung neoplasm malignant * 1  1/520 (0.19%)  0/508 (0.00%) 
Morton´s neuroma * 1  0/520 (0.00%)  1/508 (0.20%) 
Multiple myeloma * 1  1/520 (0.19%)  0/508 (0.00%) 
Oesophageal carcinoma * 1  0/520 (0.00%)  1/508 (0.20%) 
Prostatic adenoma * 1  0/520 (0.00%)  1/508 (0.20%) 
Uterine cancer * 1  0/520 (0.00%)  1/508 (0.20%) 
Nervous system disorders     
Cerebrovascular accident * 1  2/520 (0.38%)  0/508 (0.00%) 
Amytrophic lateral sclerosis * 1  1/520 (0.19%)  0/508 (0.00%) 
Cauda equina syndrome * 1  0/520 (0.00%)  1/508 (0.20%) 
Cerebral thrombosis * 1  0/520 (0.00%)  1/508 (0.20%) 
Dizziness * 1  1/520 (0.19%)  0/508 (0.00%) 
Sciatica * 1  1/520 (0.19%)  0/508 (0.00%) 
Spondylitic myelopathy * 1  1/520 (0.19%)  0/508 (0.00%) 
Subarachnoid haemorrhage * 1  1/520 (0.19%)  0/508 (0.00%) 
Trigeminal neuralgia * 1  0/520 (0.00%)  1/508 (0.20%) 
Psychiatric disorders     
Alcohol withdrawal syndrome * 1  1/520 (0.19%)  0/508 (0.00%) 
Depression * 1  1/520 (0.19%)  0/508 (0.00%) 
Renal and urinary disorders     
Stress urinary incontinence * 1  1/520 (0.19%)  1/508 (0.20%) 
Urethral stenosis * 1  0/520 (0.00%)  1/508 (0.20%) 
Urinary bladder polyp * 1  1/520 (0.19%)  0/508 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/520 (0.19%)  1/508 (0.20%) 
Prostatitis * 1  0/520 (0.00%)  1/508 (0.20%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  1/520 (0.19%)  2/508 (0.39%) 
Asthma * 1  0/520 (0.00%)  1/508 (0.20%) 
Diaphragmatic hernia * 1  1/520 (0.19%)  0/508 (0.00%) 
Dyspnoea * 1  0/520 (0.00%)  1/508 (0.20%) 
Nasal polyps * 1  1/520 (0.19%)  0/508 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/520 (0.00%)  1/508 (0.20%) 
Social circumstances     
Joint prosthesis user * 1  0/520 (0.00%)  1/508 (0.20%) 
Surgical and medical procedures     
Hip arthroplasty * 1  1/520 (0.19%)  1/508 (0.20%) 
Knee arthroplasty * 1  1/520 (0.19%)  1/508 (0.20%) 
Aortic surgery * 1  1/520 (0.19%)  0/508 (0.00%) 
Cataract operation * 1  1/520 (0.19%)  0/508 (0.00%) 
Joint arthroplasty * 1  1/520 (0.19%)  0/508 (0.00%) 
Joint stabilisation * 1  0/520 (0.00%)  1/508 (0.20%) 
Vascular disorders     
Circulatory collapse * 1  1/520 (0.19%)  0/508 (0.00%) 
Thrombosis * 1  0/520 (0.00%)  1/508 (0.20%) 
Venous stenosis * 1  0/520 (0.00%)  1/508 (0.20%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
SMC021 Oral Calcitonin SMC021 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   474/520 (91.15%)   459/508 (90.35%) 
Gastrointestinal disorders     
Nausea * 1  77/520 (14.81%)  15/508 (2.95%) 
Diarrhoea * 1  45/520 (8.65%)  27/508 (5.31%) 
Dyspepsia * 1  48/520 (9.23%)  21/508 (4.13%) 
Abdominal pain upper * 1  19/520 (3.65%)  15/508 (2.95%) 
Constipation * 1  11/520 (2.12%)  14/508 (2.76%) 
Abdominal discomfort * 1  14/520 (2.69%)  4/508 (0.79%) 
General disorders     
Oedema peripheral * 1  17/520 (3.27%)  14/508 (2.76%) 
Influenza like illness * 1  15/520 (2.88%)  14/508 (2.76%) 
Fatigue * 1  12/520 (2.31%)  5/508 (0.98%) 
Infections and infestations     
Influenza * 1  46/520 (8.85%)  40/508 (7.87%) 
Nasopharyngitis * 1  34/520 (6.54%)  39/508 (7.68%) 
Upper respiratory tract infection * 1  20/520 (3.85%)  23/508 (4.53%) 
Pneumonia * 1  20/520 (3.85%)  15/508 (2.95%) 
Cystitis * 1  13/520 (2.50%)  21/508 (4.13%) 
Viral infection * 1  16/520 (3.08%)  18/508 (3.54%) 
Bronchitis * 1  19/520 (3.65%)  11/508 (2.17%) 
Tooth infection * 1  10/520 (1.92%)  16/508 (3.15%) 
Urinary tract infection * 1  14/520 (2.69%)  10/508 (1.97%) 
Sinusitis * 1  7/520 (1.35%)  14/508 (2.76%) 
Injury, poisoning and procedural complications     
Procedural pain * 1  10/520 (1.92%)  20/508 (3.94%) 
Joint sprain * 1  7/520 (1.35%)  11/508 (2.17%) 
Contusion * 1  5/520 (0.96%)  10/508 (1.97%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia * 1  24/520 (4.62%)  24/508 (4.72%) 
Hypocalcaemia * 1  5/520 (0.96%)  10/508 (1.97%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  86/520 (16.54%)  111/508 (21.85%) 
Back Pain * 1  52/520 (10.00%)  54/508 (10.63%) 
Pain in extremity * 1  27/520 (5.19%)  23/508 (4.53%) 
Musculoskeletal pain * 1  26/520 (5.00%)  20/508 (3.94%) 
Osteoarthritis * 1  14/520 (2.69%)  25/508 (4.92%) 
Neck pain * 1  12/520 (2.31%)  8/508 (1.57%) 
Nervous system disorders     
Headache * 1  26/520 (5.00%)  27/508 (5.31%) 
Dizziness * 1  32/520 (6.15%)  17/508 (3.35%) 
Sciatica * 1  11/520 (2.12%)  7/508 (1.38%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  16/520 (3.08%)  15/508 (2.95%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  13/520 (2.50%)  9/508 (1.77%) 
Erythema * 1  15/520 (2.88%)  1/508 (0.20%) 
Vascular disorders     
Hot flush * 1  88/520 (16.92%)  22/508 (4.33%) 
Hypertension * 1  31/520 (5.96%)  39/508 (7.68%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
The study showed an underexposure to calcitonin compared to what was expected from phase I trials.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Bente Juel Riis, Medical Director
Organization: Nordic Bioscience A/S
Phone: +45 22901317
EMail: bjr@nordicbioscience.com
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Responsible Party: Nordic Bioscience A/S
ClinicalTrials.gov Identifier: NCT00704847     History of Changes
Other Study ID Numbers: CSMC021C2302
First Submitted: June 24, 2008
First Posted: June 25, 2008
Results First Submitted: August 13, 2012
Results First Posted: September 12, 2012
Last Update Posted: April 24, 2019