Back Pain in Patients With Severe Osteoporosis

Osteoporosis Clinical Trial

Official title:

An Observational Study to Assess Back Pain in Patients With Severe Osteoporosis Treated With Teriparatide Versus Antiresorptives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761332
• Other study ID #: 11837
• Secondary ID: B3D-CR-B013
• Status: Completed
• Phase: N/A
• First received: September 25, 2008
• Last updated: June 20, 2011
• Start date: February 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2011
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionIndia: Institutional Review BoardTaiwan: Institutional Review BoardSouth Korea: Institutional Review BoardSingapore: Domain Specific Review BoardsHong Kong: Ethics CommitteeThailand: Ethical CommitteeMalaysia: Ministry of HealthPakistan: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• teriparatide
treatment will be prescribed according to usual standard of care
• antiresorptives
treatment will be prescribed according to usual standard of care

Locations

Country	Name	City	State
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.	Pokfulam
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.	Ahmedabad
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
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
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
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
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.	Suwon-City
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.	Georgetown
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.	Guadalajara
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.	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
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.	Singapore
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.	Taichung City
Thailand	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Hong Kong,  India,  Korea, Republic of,  Malaysia,  Mexico,  Pakistan,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New or worsening back pain as measured by a specific question in the Back Pain Questionnaire		12 months	No
Secondary	Risk of developing moderate or severe back pain		12 months	No
Secondary	Changes in back pain severity using a Visual Analog Scale		12 months	No
Secondary	Treatment persistence, (days on therapy)		12 months	No
Secondary	Changes in health-related quality of life by completing the EuroQoL Scale (EQ-5D)		12 months	No
Secondary	Incidence of nontraumatic osteoporotic fractures		12 months	No
Secondary	Incidence of adverse events		12 months	Yes