A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

Nordic Bioscience

Status and phase

Completed

Phase 3

Conditions

Osteoporosis

Treatments

Drug: SMC021 Placebo

Drug: SMC021 Oral calcitonin

Study type

Interventional

Funder types

Industry

Identifiers

SMC021A2303

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 osteoporosis

Enrollment

4,665 patients

Sex

Female

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Postmenopausal women with osteoporosis, ambulatory, in general good health, not receiving medication that affects bone metabolism, and free from any underlying condition, other than osteoporosis, that may result in abnormal bone metabolism.

Exclusion criteria

BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at one or more of the measured sites
More than 2 prevalent vertebral fractures (Genant et al, 15).
If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture (Genant et al, 15).
Evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture (excluding wrist fractures)
BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip.

Other protocol defined inclusion/exclusion criteria may apply