Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486434
• Other study ID #: CSMC021C2301
• Status: Completed
• Phase: Phase 3
• Start date: May 2007
• Est. completion date: September 2010

Study information

• Verified date: April 2019
• Source: Nordic Bioscience A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoarthritis of the knee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1176
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 51 Years to 80 Years

Eligibility

Inclusion Criteria:

• Medical history and symptoms of knee osteoarthritis

Exclusion Criteria:

• Any other disease or medication affecting the bone or cartilage.

• Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.

Other protocol defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• SMC021 Oral Calcitonin
0.8mg SMC021 (Oral Calcitoinin) twice daily
• SMC021 Placebo
Placebo orally, twice daily

Locations

Country	Name	City	State
Czechia	CCBR Czech	Pardubice
Denmark	CCBR Aalborg	Aalborg
Denmark	CCBR Ballerup	Ballerup
Denmark	CCBR Vejle	Vejle
Estonia	CCBR Estonia	Tallinn
Hong Kong	CCBR Hong Kong	Hong Kong
Poland	Centrum Osteoporozy i Chorób Kostno Stawowych, ul. Warynskiego 6/2	Bialystok
Poland	CCBR Poland	Warsaw
Romania	CCBR Romania	Bucharest

Sponsors (2)

Lead Sponsor	Collaborator
Nordic Bioscience A/S	Novartis

Countries where clinical trial is conducted

Czechia,  Denmark,  Estonia,  Hong Kong,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.	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.	Change from baseline to 24 months
Primary	Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore 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 pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function 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).	Change from baseline to 24 months
Primary	Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore 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 difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).	Change from baseline to 24 months
Secondary	Changes in Biochemical Markers of Bone & Cartilage Metabolism.	The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done.	From Baseline to Month 24
Secondary	Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months	To assess disease progression of OA affected joints, X-rays of both hands were performed & assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, & joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses.; The AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated.	Baseline and Month 24
Secondary	Nature and # of AEs Monitored Continuously During Study	Adverse events were by system organ class of all patients.	From Baseline to Month 24
Secondary	Disease Progression in the Knee Evaluated by MRI.	Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for 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.	From Baseline to Month 24