Back Pain in Patients With Severe Osteoporosis
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: teriparatide (Drug); antiresorptives (Drug)
Phase: N/A
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: An Observational Study to Assess Back Pain in Patients With Severe Osteoporosis Treated With Teriparatide Versus Antiresorptives
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: New or worsening back pain as measured by a specific question in the Back Pain Questionnaire
Secondary outcome: Risk of developing moderate or severe back painChanges in back pain severity using a Visual Analog Scale Treatment persistence, (days on therapy) Changes in health-related quality of life by completing the EuroQoL Scale (EQ-5D) Incidence of nontraumatic osteoporotic fractures Incidence of adverse events
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).
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 and Contacts
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
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 380006, India
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 122020, India
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 500001, India
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., Nagpur 440010, India
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., New Delhi 110070, India
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., Suwon-City 442-721, Korea, Republic of
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., Georgetown 10450, Malaysia
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., Guadalajara 44670, Mexico
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., Islamabad, Pakistan
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., Lahore, Pakistan
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., Rawalpindi 46000, Pakistan
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., Singapore 529889, Singapore
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., Taichung City 40201, Taiwan
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 10400, Thailand
Additional Information
Starting date: February 2008
Last updated: June 20, 2011
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