Back Pain in Patients With Severe Osteoporosis

Eli Lilly and Company650 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

650

Conditions

Osteoporosis

Interventions

teriparatideDRUG

treatment will be prescribed according to usual standard of care

antiresorptivesDRUG

treatment will be prescribed according to usual standard of care

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (15)

Outcomes

Primary Outcomes

New or worsening back pain as measured by a specific question in the Back Pain Questionnaire

Time frame: 12 months

Secondary Outcomes

Risk of developing moderate or severe back pain

Time frame: 12 months

Changes in back pain severity using a Visual Analog Scale

Time frame: 12 months

Treatment persistence, (days on therapy)

Time frame: 12 months

Changes in health-related quality of life by completing the EuroQoL Scale (EQ-5D)

Time frame: 12 months

Incidence of nontraumatic osteoporotic fractures

Time frame: 12 months

Incidence of adverse events

Time frame: 12 months

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Pokfulam, Hong Kong

Ahmedabad, India

Gūrgaon, India

Hyderabaad, India

Nagpur, India

New Delhi, India

George Town, Malaysia

Guadalajara, Mexico

Islamabad, Pakistan

Lahore, Pakistan

...and 5 more locations