NCT00239889

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
Last Updated

November 30, 2006

Status Verified

March 1, 2006

First QC Date

October 13, 2005

Last Update Submit

November 29, 2006

Conditions

Forearm Fracture

Keywords

Forearm fracturePostmenopausal womenPainGrip strengthSalmon calcitonin

Outcome Measures

Primary Outcomes (1)

  • Grip strength of the injured arm after 24 weeks

Secondary Outcomes (4)

  • 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.

Interventions

Salmon calcitoninDRUG

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis

Nuremberg, Germany

Location

Novartis

Basel, Switzerland

Location

MeSH Terms

Conditions

Pain

Interventions

salmon calcitonin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Basel 41 61 324 1111

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

March 1, 2002

Last Updated

November 30, 2006

Record last verified: 2006-03

Locations

CH(1)DE(1)