The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

Back Pain Clinical Trial

Official title:

A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 µg PTH(1-84) Daily or 70 mg Alendronate Weekly

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00713258
• Other study ID #: FP-005-IM
• Status: Terminated
• Phase: Phase 4
• First received: July 2, 2008
• Last updated: May 4, 2012
• Start date: April 2008
• Est. completion date: September 2010

Study information

• Verified date: May 2012
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesItaly: The Italian Medicines AgencySpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: September 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Postmenopausal women with a T-score = -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.

Exclusion Criteria:

• Previous/current treatment and medical history.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Fractures, Bone
• Osteoporosis
• Spinal Fractures

Intervention

Drug:
• Parathyroid hormone (PTH) (1-84)
100 µg PTH(1-84) daily
• Alendronate
70 mg alendronate weekly

Locations

Country	Name	City	State
Denmark	Nycomed	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.	The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = "no pain" and 10 = "unendurable pain").	Baseline and 24 weeks treatment	No
Secondary	Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment	Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person's functional level is restricted by pain.; ODI scores from 0 = "no disability" to 100 = "maximum disability".; Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status.	Baseline and 24 weeks treatment	No