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

EUCTR2007-003016-60-DK

Enrollment

920

Registered

2007-09-20

Start date

2007-10-12

Completion date

Unknown

Last updated

2012-08-21

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

Conditions

Osteoarthritis 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 Concentration unit: mg milligram(s) Concentration typ

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-rays of the knee. ;Secondary Objective: Pain and functional disability assessed by the WOMAC Questionnaire Safety;Primary end point(s): Joint Space Width (JSW) in the medial tibio-femoral knee joint in the signal knee measured by X-ray	—

Countries

Denmark, Poland, Spain, United Kingdom

Outcome results

None listed

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