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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00239889 |
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.
Condition | Intervention | Phase |
---|---|---|
Forearm Fracture |
Drug: Salmon calcitonin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women |
Estimated Enrollment: | 300 |
Study Start Date: | March 2002 |
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CSMC051A2402 |
Study First Received: | October 13, 2005 |
Last Updated: | November 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00239889 History of Changes |
Health Authority: | Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Portugal: National Pharmacy and Medicines Institute; Russia: Pharmacological Committee, Ministry of Health |
Forearm fracture Postmenopausal women Pain Grip strength Salmon calcitonin |
Calcitonin Gene-Related Peptide Calcitonin Vasodilator Agents Fractures, Bone Wounds and Injuries Influenza, Human |
Disorders of Environmental Origin Bone Density Conservation Agents Pain Cardiovascular Agents Salmon calcitonin |
Calcitonin Gene-Related Peptide Calcitonin Vasodilator Agents Therapeutic Uses Physiological Effects of Drugs Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Bone Density Conservation Agents Cardiovascular Agents Salmon calcitonin Pharmacologic Actions |