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)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Back Pain

Intervention / Treatment
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* Drug: Parathyroid hormone (PTH) (1-84)
* Drug: Alendronate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PTH (1-84)<br>PTH (1-84) + placebo alendronate | Drug: Parathyroid hormone (PTH) (1-84)<br>* 100 µg PTH(1-84) daily<br>|
| Active Comparator: Alendronate<br>PTH (1-84) placebo + alendronate | Drug: Alendronate<br>* 70 mg alendronate weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline and 24 weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal women, Back pain, Osteoporosis related fracture