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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT00239889 (opens ClinicalTrials.gov in a new tab)Other idCSMC051A2402
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
300 participants
Sponsor
Novartis · Industry
Design
Randomized · Double masking
Countries
2 countries

Germany, Switzerland

Start
Mar 2002
Primary completion
Not stated
Completion
Not stated
First posted
17 Oct 2005 (estimated)
Last update posted
30 Nov 2006 (estimated)
Conditions
Forearm Fracture

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022003
  1. Ph 4

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

    NCT00239889

    Start Mar 2002

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Salmon calcitoninDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Grip strength of the injured arm after 24 weeks

Secondary outcomes(4)

  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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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