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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
100 µg PTH(1-84) daily
70 mg alendronate weekly
Nycomed
Roskilde, Denmark
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").
Time frame: Baseline and 24 weeks treatment
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.
Time frame: Baseline and 24 weeks treatment
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