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

Nordic Bioscience

Status and phase: Terminated; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Oral Salmon Calcitonin (Placebo); Drug: Oral Salmon Calcitonin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00704847

CSMC021C2302

Details and patient eligibility

About

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

Enrollment: 1,030 patients

Sex: All

Ages: 51 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,030 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

SMC021 Oral Calcitonin

Treatment:

Drug: Oral Salmon Calcitonin

2

Placebo Comparator group

Description:

SMC021 Placebo

Treatment:

Drug: Oral Salmon Calcitonin (Placebo)