Back Pain in Patients With Severe Osteoporosis

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

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.

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.