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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00239889

Purpose

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Flu Fractures

Drug Information available for: Calcitonin human Calcitonin Fortical

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Grip strength of the injured arm after 24 weeks

Secondary Outcome Measures:

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.
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.
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.
Grip strength in the injured arm at cast removal and at 1, 2, 4 and 10 weeks after cast removal.

Estimated Enrollment:	300
Study Start Date:	March 2002

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239889

Locations

Germany
Novartis
Nuernberg, Germany
Switzerland
Novartis
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Basel 41 61 324 1111

Novartis

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00239889 History of Changes
Other Study ID Numbers:	CSMC051A2402
Study First Received:	October 13, 2005
Last Updated:	November 29, 2006
Health Authority:	Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Portugal: National Pharmacy and Medicines Institute; Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Novartis:

Forearm fracture
Postmenopausal women
Pain
Grip strength
Salmon calcitonin

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents

Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012