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)

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2010

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: PTH (1-84)
    • PTH (1-84) + placebo alendronate
  • Active Comparator: Alendronate
    • PTH (1-84) placebo + alendronate

Clinical Trial Outcome Measures

Primary Measures

  • Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
    • Time Frame: 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 Measures

  • Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nycomed
  • Provider of Information About this Clinical Study
    • Sponsor

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