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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoporosis

In brief

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

Key facts

Study ID

NCT00525798

Run by

Nordic Bioscience A/S

People needed

4665

Starts

2007-03-01

Expected to finish

2011-11-01

Last updated by the study team

2012-10-29

Who can join

Age: 55 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• United Osteporosis Centers — Gainesville, Georgia, United States
• Michigan Bone & Mineral Clinic PC, — Detroit, Michigan, United States
• Oregon Osteoporosis Center — Portland, Oregon, United States
• CCBR Brazil — Rio de Janeiro, Brazil
• CCBR China — Beijing, China
• CCBR Czech — Pardubice, Czechia
• CCBR Aalborg — Aalborg, Denmark
• CCBR Ballerup — Ballerup Municipality, Denmark
• CCBR Vejle — Vejle, Denmark
• CCBR Estonia — Tallinn, Estonia
• Hopital Edouard Herriot — Lyon, France
• CCBR Hong Kong — Hong Kong, Hong Kong
• Department of Internal Medicine, University of Florence — Florence, Italy
• CCBR Lithuania — Vilnius, Lithuania
• CCBR Poland — Warsaw, Poland
• CCBR Romania — Bucharest, Romania

Full record on ClinicalTrials.gov

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