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)
Information source: Nycomed
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Back Pain
Intervention: Parathyroid hormone (PTH) (1-84) (Drug); Alendronate (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Nycomed
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
Secondary outcome: Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Nycomed, Roskilde 4000, Denmark
Additional Information
Starting date: April 2008
Last updated: May 4, 2012
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