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

Nordic Bioscience A/S1,176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,176

Conditions

Osteoarthritis

Interventions

SMC021 Oral CalcitoninDRUG

0.8mg SMC021 (Oral Calcitoinin) twice daily

SMC021 PlaceboDRUG

Placebo orally, twice daily

Eligibility

Sex: ALLMin age: 51 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (9)

CCBR Czech

Pardubice, Czechia

CCBR Aalborg

Aalborg, Denmark

CCBR Ballerup

Ballerup Municipality, Denmark

CCBR Vejle

Vejle, Denmark

Outcomes

Primary Outcomes

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.

Time frame: Change from baseline to 24 months

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).

Time frame: Change from baseline to 24 months

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).

Time frame: Change from baseline to 24 months

Secondary Outcomes

Data from ClinicalTrials.gov

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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.

Time frame: Baseline and Month 24