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)

Phase 4

Terminated

• Conditions: Back Pain
• Interventions: Drug: Parathyroid hormone (PTH) (1-84); Drug: Alendronate

• Registration Number: NCT00713258
• Lead Sponsor: Nycomed

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-11
• Primary Completion: 2010-05
• Study Completion: 2010-09
• Results First Submitted: 2011-07-28
• Results First Submitted QC: 2011-09-02
• Results First Posted: 2011-10-07
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTH (1-84)	Parathyroid hormone (PTH) (1-84)	PTH (1-84) + placebo alendronate
Alendronate	Alendronate	PTH (1-84) placebo + alendronate

Primary Outcome Measures

Name	Time	Method
Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.	Baseline and 24 weeks treatment	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").

Secondary Outcome Measures

Name	Time	Method
Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment	Baseline and 24 weeks 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.

Trial Locations

Locations (1)

Nycomed; 🇩🇰 Roskilde, Denmark