Back Pain in Patients With Severe Osteoporosis

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectiveness of teriparatide versus therapies that decrease bone loss to prevent new or worsening back pain in patients with osteoporosis seen in clinical practice.

Detailed Description
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Study B3D-CR-B013 is a prospective observational study to compare changes in back pain among patients treated with teriparatide versus those treated with antiresorptives (raloxifene, daily or weekly bisphosphonates).

Official Title
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An Observational Study to Assess Back Pain in Patients With Severe Osteoporosis Treated With Teriparatide Versus Antiresorptives

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: teriparatide
* Drug: antiresorptives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and postmenopausal women who have a previous vertebral osteoporotic fracture that was sustained at least 6 weeks prior to joining the study. Patients who are free of severe or chronically disabling conditions other than osteoporosis. Patients who are not currently receiving and have not previously received teriparatide. Patients who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study. Patients, who in the opinion of the prescribing physician, are eligible to receive the intended treatment and comply with all the recommendations stated in the relevant product information. Exclusion Criteria: Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. Are Lilly employees (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Patients who have any contraindications according to the relevant product information in the country in which they are being treated. Patients who are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Teriparatide<br>Patients treated with teriparatide | Drug: teriparatide<br>* treatment will be prescribed according to usual standard of care<br>* Other names: LY333334;|
| Antiresorptive<br>Patients treated with antiresorptive therapy | Drug: antiresorptives<br>* treatment will be prescribed according to usual standard of care<br>* Other names: raloxifene, daily or weekly bisphosphonates;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New or worsening back pain as measured by a specific question in the Back Pain Questionnaire |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of developing moderate or severe back pain |  | 12 months | 
| Changes in back pain severity using a Visual Analog Scale |  | 12 months | 
| Treatment persistence, (days on therapy) |  | 12 months | 
| Changes in health-related quality of life by completing the EuroQoL Scale (EQ-5D) |  | 12 months | 
| Incidence of nontraumatic osteoporotic fractures |  | 12 months | 
| Incidence of adverse events |  | 12 months |