Trial Outcomes & Findings for 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) (NCT NCT00713258)
NCT ID: NCT00713258
Last Updated: 2012-05-08
Results Overview
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").
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
75 participants
Primary outcome timeframe
Baseline and 24 weeks treatment
Results posted on
2012-05-08
Participant Flow
Participant milestones
| Measure |
PTH (1-84)
PTH (1-84) + placebo alendronate
* PTH (1-84): powder and solvent for solution for injection
* placebo alendronate: capsule
|
Alendronate
PTH (1-84) placebo + alendronate
* PTH (1-84) placebo: powder and solvent for solution for injection
* alendronate: capsule
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
34
|
|
Overall Study
COMPLETED
|
36
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
PTH (1-84)
PTH (1-84) + placebo alendronate
* PTH (1-84): powder and solvent for solution for injection
* placebo alendronate: capsule
|
Alendronate
PTH (1-84) placebo + alendronate
* PTH (1-84) placebo: powder and solvent for solution for injection
* alendronate: capsule
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
|
Overall Study
Non-Compliance
|
2
|
1
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
PTH (1-84)
n=41 Participants
PTH (1-84) + placebo alendronate
* PTH (1-84): powder and solvent for solution for injection
* placebo alendronate: capsule
|
Alendronate
n=34 Participants
PTH (1-84) placebo + alendronate
* PTH (1-84) placebo: powder and solvent for solution for injection
* alendronate: capsule
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70.7 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 7.84 • n=7 Participants
|
70.3 years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
41 participants
n=5 Participants
|
34 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Vertebral Fracture at Baseline
|
3.44 vertebral fractures per patient
STANDARD_DEVIATION 2.49 • n=5 Participants
|
2.94 vertebral fractures per patient
STANDARD_DEVIATION 1.97 • n=7 Participants
|
3.21 vertebral fractures per patient
STANDARD_DEVIATION 2.27 • n=5 Participants
|
|
Family history of osteoporosis
|
13 patients
n=5 Participants
|
9 patients
n=7 Participants
|
22 patients
n=5 Participants
|
|
Age at onset of menopause
|
48.5 years
STANDARD_DEVIATION 3.68 • n=5 Participants
|
48.6 years
STANDARD_DEVIATION 5.25 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 4.43 • n=5 Participants
|
|
Mean NRS score
|
6.60 scores on a scale
STANDARD_DEVIATION 1.45 • n=5 Participants
|
6.36 scores on a scale
STANDARD_DEVIATION 1.70 • n=7 Participants
|
6.49 scores on a scale
STANDARD_DEVIATION 1.56 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeks treatmentPopulation: 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.
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").
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 24 weeks treatmentPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
PTH (1-84)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Alendronate
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PTH (1-84)
n=41 participants at risk
PTH (1-84) + placebo alendronate
* PTH (1-84): powder and solvent for solution for injection
* placebo alendronate: capsule
|
Alendronate
n=34 participants at risk
PTH (1-84) placebo + alendronate
* PTH (1-84) placebo: powder and solvent for solution for injection
* alendronate: capsule
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/41 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
2.9%
1/34 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/41 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
2.9%
1/34 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/41 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
2.9%
1/34 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/41 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
2.9%
1/34 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/41 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
2.9%
1/34 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
2.4%
1/41 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
0.00%
0/34 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
Other adverse events
| Measure |
PTH (1-84)
n=41 participants at risk
PTH (1-84) + placebo alendronate
* PTH (1-84): powder and solvent for solution for injection
* placebo alendronate: capsule
|
Alendronate
n=34 participants at risk
PTH (1-84) placebo + alendronate
* PTH (1-84) placebo: powder and solvent for solution for injection
* alendronate: capsule
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/41 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
5.9%
2/34 • Number of events 2 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
3/41 • Number of events 3 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
2.9%
1/34 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
2/41 • Number of events 2 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
11.8%
4/34 • Number of events 4 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
24.4%
10/41 • Number of events 11 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
0.00%
0/34 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
1/41 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
5.9%
2/34 • Number of events 2 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
5.9%
2/34 • Number of events 2 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.4%
1/41 • Number of events 1 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
5.9%
2/34 • Number of events 2 • 24 weeks
The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After publication of the results or 24 months after Clinical Trial Report has been finalised, whichever comes first, Nycomed acknowledge the Investigator's rights to publish results from this trial. Any such scientific paper, presentation, communication or other information concerning the trial described in this protocol must be submitted to Nycomed for review prior to submission for publication/presentation. Review comments will be given within a month from receipt of the manuscript.
- Publication restrictions are in place
Restriction type: OTHER