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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

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ClinicalTrials.gov Identifier: NCT00239889
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : November 30, 2006
Sponsor:
Information provided by:
Novartis

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Forearm Fracture Drug: Salmon calcitonin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Grip strength of the injured arm after 24 weeks

Secondary Outcome Measures :
  1. 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.
  2. 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.
  3. 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.
  4. Grip strength in the injured arm at cast removal and at 1, 2, 4 and 10 weeks after cast removal.

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239889


Locations
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Germany
Novartis
Nuernberg, Germany
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Study Chair: Novartis Basel 41 61 324 1111 Novartis
More Information
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ClinicalTrials.gov Identifier: NCT00239889    
Other Study ID Numbers: CSMC051A2402
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: November 30, 2006
Last Verified: March 2006
Keywords provided by Novartis:
Forearm fracture
Postmenopausal women
Pain
Grip strength
Salmon calcitonin
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
 Katacalcin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents