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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004145-34-DK

Enrollment

1150

Registered

2005-09-21

Start date

2005-10-20

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is a phase III trial. The population will be ambulatory men and women with knee osteoarthritis between 51 and 80 years old, in general good health. MedDRA version: 9.1 Level: LLT Classification code 10031161 Term: Osteoarthritis

Interventions

Product Name: Oral Calcitonin Product Code: SMC021 Pharmaceutical Form: Tablet INN or Proposed INN: Salmon calcitonin Current Sponsor code: SMC021 Other descriptive name: Oral Calcitonin Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Ambulatory men and women with knee osteoarthritis, between 51 and 80 years old, in general good health. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Any disease or medication affecting the bone or cartilage metabolism (osteoporosis is allowed). • Conditions causing secondary osteoarthritis of the study joint • Obese study subjects with unilateral aggressive progressing knee OA. • Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years. • Any clinical signs or laboratory evidence for severe renal/liver/pulmonary, neurologic, cardiovascular, metabolic, hematological or psychiatric condition, which in the Investigator’s opinion would preclude the participant from adhering to the Protocol or completing the trial. • Diagnostic arthroscopy with a surgical procedure within 6 moths prior to the screening or plan to have a surgery during the clinical trial. • History of drug abuse or active alcoholism. • Any investigational drug(s) within 30 days prior to screening.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this trial is to study the effect on joint space width (JSW) measured by X-ray, pain and functional disability assessed by the WOMAC Questionnaire of oral calcitonin treatment in subjects with osteoarthritis of the knee (OA).;Secondary Objective: JSW, pain and disability in the other knee Hand Osteoarthritis Safety;Primary end point(s): The aim of the trial is to study the effect of oral calcitonin compared to placebo with three primary endpoints: 1.JSW in the medial tibio-femoral knee joint in the signal knee measured by X-ray 2. Pain to be assesses by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain sub score in the signal knee 3. Functional disability to be assessed by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) function sub score in the signal knee.	—

Measure

Time frame

Main Objective: The main objective of this trial is to study the effect on joint space width (JSW) measured by X-ray, pain and functional disability assessed by the WOMAC Questionnaire of oral calcitonin treatment in subjects with osteoarthritis of the knee (OA).;Secondary Objective: JSW, pain and disability in the other knee Hand Osteoarthritis Safety;Primary end point(s): The aim of the trial is to study the effect of oral calcitonin compared to placebo with three primary endpoints: 1.JSW in the medial tibio-femoral knee joint in the signal knee measured by X-ray 2. Pain to be assesses by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain sub score in the signal knee 3. Functional disability to be assessed by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) function sub score in the signal knee.

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Countries

Denmark, Estonia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026