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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239889

Enrollment

300

Registered

2005-10-17

Start date

2002-03-31

Completion date

Unknown

Last updated

2006-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Forearm Fracture

Keywords

Forearm fracture, Postmenopausal women, Pain, Grip strength, Salmon calcitonin

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.

Interventions

DRUGSalmon calcitonin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

60 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Grip strength of the injured arm after 24 weeks	—

Secondary

Measure	Time frame
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.	—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026