Skip to main content
OpenTrials
Completed

NCT Number: NCT00239889

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Forearm Fracture Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Novartis, Nuremberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salmon Calcitonin

Drug

Primary outcomes

  1. Grip strength of the injured arm after 24 weeks

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2002
First posted
Oct 17, 2005
Registry last updated
Nov 30, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.