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

Nordic Bioscience

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: SMC021 Placebo; Drug: SMC021 Oral Calcitonin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486434

CSMC021C2301

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: 1,176 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

---

1,176 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months

Treatment:

Drug: SMC021 Oral Calcitonin

2

Placebo Comparator group

Description:

SMC021 Placebo, orally twice daily during 24 months

Treatment:

Drug: SMC021 Placebo