Back Pain
Conditions
Keywords
Postmenopausal women, Back pain, Osteoporosis related fracture
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).
Interventions
100 µg PTH(1-84) daily
DRUGAlendronate
70 mg alendronate weekly
Sponsors
Nycomed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PTH (1-84) PTH (1-84) + placebo alendronate
* PTH (1-84): powder and solvent for solution for injection
* placebo alendronate: capsule | 41 |
| Alendronate PTH (1-84) placebo + alendronate
* PTH (1-84) placebo: powder and solvent for solution for injection
* alendronate: capsule | 34 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 |
| Overall Study | Non-Compliance | 2 | 1 |
| Overall Study | Other | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Alendronate | PTH (1-84) |
|---|---|---|---|
| Age at onset of menopause | 48.5 years STANDARD_DEVIATION 4.43 | 48.6 years STANDARD_DEVIATION 5.25 | 48.5 years STANDARD_DEVIATION 3.68 |
| Age Continuous | 70.3 years STANDARD_DEVIATION 8.53 | 69.8 years STANDARD_DEVIATION 7.84 | 70.7 years STANDARD_DEVIATION 9.14 |
| Family history of osteoporosis | 22 patients | 9 patients | 13 patients |
| Mean NRS score | 6.49 scores on a scale STANDARD_DEVIATION 1.56 | 6.36 scores on a scale STANDARD_DEVIATION 1.7 | 6.60 scores on a scale STANDARD_DEVIATION 1.45 |
| Sex/Gender, Customized Female | 75 participants | 34 participants | 41 participants |
| Vertebral Fracture at Baseline | 3.21 vertebral fractures per patient STANDARD_DEVIATION 2.27 | 2.94 vertebral fractures per patient STANDARD_DEVIATION 1.97 | 3.44 vertebral fractures per patient STANDARD_DEVIATION 2.49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 41 | 13 / 34 |
| serious Total, serious adverse events | 1 / 41 | 5 / 34 |
Outcome results
Primary
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
Population: The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity.
Secondary
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
Population: The number of participants analyzed is 0, because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity.