Back Pain in Patients With Severe Osteoporosis

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).

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.