Not provided
Not provided
Not provided
Not provided
Not provided
Slow enrolment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTH (1-84) | Active Comparator | PTH (1-84) + placebo alendronate |
|
| Alendronate | Active Comparator | PTH (1-84) placebo + alendronate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parathyroid hormone (PTH) (1-84) | Drug | 100 µg PTH(1-84) daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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"). | Baseline and 24 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed | Roskilde | 4000 | Denmark |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PTH (1-84) | PTH (1-84) + placebo alendronate
|
| FG001 | Alendronate | PTH (1-84) placebo + alendronate
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Alendronate |
| Drug |
70 mg alendronate weekly |
|
| Baseline and 24 weeks treatment |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PTH (1-84) | PTH (1-84) + placebo alendronate
|
| BG001 | Alendronate | PTH (1-84) placebo + alendronate
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Number | participants |
| ||||||||||||||||
| Vertebral Fracture at Baseline | The baseline measure is shown as average number per patient. | Mean | Standard Deviation | vertebral fractures per patient |
| ||||||||||||||
| Family history of osteoporosis | A family history of osteoporosis was reported by 22 subjects, which differs from the overall number of baseline participants. | Number | patients |
| |||||||||||||||
| Age at onset of menopause | Mean | Standard Deviation | years |
| |||||||||||||||
| Mean NRS score | NRS = 11-point numerical rating scale to assess the pain. The NRS score ranges from 0 to 10, with lower scores meaning less pain. | Mean | Standard Deviation | scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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"). | 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. | Posted | Mean | Standard Deviation | points on a scale | Baseline and 24 weeks treatment |
|
| |||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 24 weeks treatment |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PTH (1-84) | PTH (1-84) + placebo alendronate
| 1 | 41 | 18 | 41 | ||
| EG001 | Alendronate | PTH (1-84) placebo + alendronate
| 5 | 34 | 13 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment | non-serious |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
Early termination leading to small number of subjects analyzed.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Operations | Nycomed | +45 4677 1111 | clinicaltrials@nycomed.com |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Units | Counts |
|---|---|
| Participants |
|