Back Pain in Patients With Severe Osteoporosis

Lilly

Status

Completed

Conditions

Osteoporosis

Treatments

Drug: teriparatide

Drug: antiresorptives

Study type

Observational

Funder types

Industry

Identifiers

NCT00761332

B3D-CR-B013 (Other Identifier)

11837

Details and patient eligibility

About

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.

Full description

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).

Enrollment

650 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.