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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00239889
First received: October 13, 2005
Last updated: November 29, 2006
Last verified: March 2006
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Calcitonin
Calcitonin Gene-Related Peptide
Salmon calcitonin
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014