Back to resultsEfficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
Primary Purpose
Forearm Fracture
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Salmon calcitonin
Sponsored by
About this trial
This is an interventional treatment trial for Forearm Fracture focused on measuring Forearm fracture, Postmenopausal women, Pain, Grip strength, Salmon calcitonin
Eligibility 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.
Sites / Locations
- Novartis
- Novartis
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00239889
Brief Title
Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
Official Title
Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forearm Fracture
Keywords
Forearm fracture, Postmenopausal women, Pain, Grip strength, Salmon calcitonin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Salmon calcitonin
Primary Outcome Measure Information:
Title
Grip strength of the injured arm after 24 weeks
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
Grip strength in the injured arm at cast removal and at 1, 2, 4 and 10 weeks after cast removal.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Basel 41 61 324 1111
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
Nuernberg
Country
Germany
Facility Name
Novartis
City
Basel
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
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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