- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00713258
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)
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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Roskilde, Denmark, 4000
- Nycomed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: PTH (1-84)
PTH (1-84) + placebo alendronate
|
100 µg PTH(1-84) daily
|
ACTIVE_COMPARATOR: Alendronate
PTH (1-84) placebo + alendronate
|
70 mg alendronate weekly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
Time Frame: 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").
|
Baseline and 24 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment
Time Frame: 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. |
Baseline and 24 weeks treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Pain
- Neurologic Manifestations
- Fractures, Bone
- Wounds and Injuries
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Spinal Injuries
- Back Injuries
- Back Pain
- Osteoporosis
- Spinal Fractures
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Alendronate
- Hormones
- Parathyroid Hormone
Other Study ID Numbers
- FP-005-IM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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