Back Pain in Patients With Severe Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00761332
First received: September 25, 2008
Last updated: June 20, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Osteoporosis
Drug: teriparatide
Drug: antiresorptives

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Assess Back Pain in Patients With Severe Osteoporosis Treated With Teriparatide Versus Antiresorptives

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • New or worsening back pain as measured by a specific question in the Back Pain Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk of developing moderate or severe back pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in back pain severity using a Visual Analog Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Treatment persistence, (days on therapy) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in health-related quality of life by completing the EuroQoL Scale (EQ-5D) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of nontraumatic osteoporotic fractures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 650
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Teriparatide
Patients treated with teriparatide
Drug: teriparatide
treatment will be prescribed according to usual standard of care
Other Names:
  • Forteo
  • Forsteo
  • LY333334
Antiresorptive
Patients treated with antiresorptive therapy
Drug: antiresorptives
treatment will be prescribed according to usual standard of care
Other Name: raloxifene, daily or weekly bisphosphonates

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Routine clinical practice

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761332

Locations
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, Hong Kong
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, 380006
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
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
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, 440010
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, India, 110070
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, Korea, Republic of, 442-721
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, Malaysia, 10450
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, Mexico, 44670
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, Pakistan, 46000
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, Singapore, 529889
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, Taiwan, 40201
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, Thailand, 10400
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00761332     History of Changes
Other Study ID Numbers: 11837, B3D-CR-B013
Study First Received: September 25, 2008
Last Updated: June 20, 2011
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection
India: Institutional Review Board
Taiwan: Institutional Review Board
South Korea: Institutional Review Board
Singapore: Domain Specific Review Boards
Hong Kong: Ethics Committee
Thailand: Ethical Committee
Malaysia: Ministry of Health
Pakistan: Research Ethics Committee

Additional relevant MeSH terms:
Back Pain
Osteoporosis
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Diphosphonates
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014