Back Pain in Patients With Severe Osteoporosis

Completed

• Conditions: Osteoporosis
• Interventions: Drug: antiresorptives; Drug: teriparatide

• Registration Number: NCT00761332
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-20
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antiresorptive	antiresorptives	Patients treated with antiresorptive therapy
Teriparatide	teriparatide	Patients treated with teriparatide

Primary Outcome Measures

Name	Time	Method
New or worsening back pain as measured by a specific question in the Back Pain Questionnaire	12 months

Secondary Outcome Measures

Name	Time	Method
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
Risk of developing moderate or severe back pain	12 months
Changes in back pain severity using a Visual Analog Scale	12 months

Trial Locations

Locations (1)

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.; 🇹🇭 Bangkok, Thailand