Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Forearm Fracture
Intervention: Salmon calcitonin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Basel 41 61 324 1111, Study Chair, Affiliation: Novartis
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.
Clinical Details
Official title: Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Grip strength of the injured arm after 24 weeks
Secondary outcome: 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.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Novartis, Nuernberg, Germany
Novartis, Basel, Switzerland
Additional Information
Starting date: March 2002
Last updated: November 29, 2006
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