Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women

Forearm Fracture Clinical Trial

Official title:

Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239889
• Other study ID #: CSMC051A2402
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2005
• Last updated: November 29, 2006
• Start date: March 2002

Study information

• Verified date: March 2006
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Portugal: National Pharmacy and Medicines InstituteRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Post-menopausal women, aged at least 60 years old

• Having a forearm fracture within the last 3-7 days before treatment

• Fracture is treated with either a plaster cast only, or a cast plus Kirschner wires

Exclusion Criteria:

• Multiple fractures, severe fractures, or the forearm fractured in more than one place

• Nerve damage in the forearm caused by the fracture

• Other conditions which would interfere with the grip strength measurements (e.g. swelling, paralysis, skin diseases or rheumatoid arthritis)

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Forearm Fracture
• Fractures, Bone

Intervention

Drug:
• Salmon calcitonin

Locations

Country	Name	City	State
Germany	Novartis	Nuernberg
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grip strength of the injured arm after 24 weeks
Secondary	Post fracture pain intensity at rest in the evenings and analgesic consumption over 24 hours at Days 1-7; weeks 2, 3 and 4; the day before cast removal; 1 to 7 days and 2, 4 and 10 weeks after cast removal; and at 24 weeks after enrolment.
Secondary	Post fracture pain intensity after grip strength assessment at cast removal; at 1, 2, 4 and 10 weeks after cast removal (4-6 weeks after fracture); and at 24 weeks after enrolment.
Secondary	Incidence of complex regional pain syndrome (CRPS) type 1/reflex sympathetic dystrophy (RSD) at cast removal; at 1, 2, 4 and 10 weeks after cast removal; and at 24 weeks after enrolment.
Secondary	Grip strength in the injured arm at cast removal and at 1, 2, 4 and 10 weeks after cast removal.