Back to resultsThe 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)
Primary Purpose
Back Pain
Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Parathyroid hormone (PTH) (1-84)
Alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring Postmenopausal women, Back pain, Osteoporosis related fracture
Eligibility Criteria
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.
Sites / Locations
- Nycomed
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PTH (1-84)
Alendronate
Arm Description
PTH (1-84) + placebo alendronate
PTH (1-84) placebo + alendronate
Outcomes
Primary Outcome Measures
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").
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00713258
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow enrolment
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nycomed
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
Postmenopausal women, Back pain, Osteoporosis related fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PTH (1-84)
Arm Type
Active Comparator
Arm Description
PTH (1-84) + placebo alendronate
Arm Title
Alendronate
Arm Type
Active Comparator
Arm Description
PTH (1-84) placebo + alendronate
Intervention Type
Drug
Intervention Name(s)
Parathyroid hormone (PTH) (1-84)
Intervention Description
100 µg PTH(1-84) daily
Intervention Type
Drug
Intervention Name(s)
Alendronate
Intervention Description
70 mg alendronate weekly
Primary Outcome Measure Information:
Title
Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
Description
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").
Time Frame
Baseline and 24 weeks treatment
Secondary Outcome Measure Information:
Title
Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment
Description
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.
Time Frame
Baseline and 24 weeks treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nycomed
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
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)
We'll reach out to this number within 24 hrs