Status:
COMPLETED
Back Pain in Patients With Severe Osteoporosis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Osteoporosis
Eligibility:
All Genders
40+ years
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 ...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00761332
Start Date
February 1 2008
End Date
December 1 2010
Last Update
June 21 2011
Active Locations (15)
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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.
Pokfulam, Hong Kong
2
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.
Ahmedabad, India, 380006
3
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.
Gurgaon, India, 122020
4
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.
Hyderabaad, India, 500001