Study of FORTEO Use in Subjects in the Community Setting

NCT01078805 | Completed Results

• 2 other identifiers: 8492B3D-US-GHCQ
• Study Type: observational
• Target: 4,167
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of FORTEO in a larger, more diverse "real world" population than studied in clinical trials

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Non-Vertebral Fragility Fractures

  Non-vertebral fragility fracture is defined as low trauma fracture, such as a fall from standing height. It is binary outcome (Yes/No). Percentage of participants = number of participants with new Non-Vertebral Fragility Fracture/ number of participants at risk \* 100.

  up to 24 months

Secondary Outcomes (8)

• Percentage of Participants With Clinical Vertebral Fractures

  up to 24 months

• Percentage Change From Baseline in Back Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint

  Baseline, Month 24

• Percentage Change From Baseline in Pain Score by Visual Analog Scale (VAS) at 24 Month Endpoint

  Baseline, Month 24

• Treatment Adherence

  up to 24 months

• Percentage Change From Baseline in Bone Mineral Density (BMD) at Month 24 Endpoint

  Baseline, up to month 24

Study Arms (1)

FORTEO (teriparatide)-treated

FORTEO-treated

Drug: FORTEO

Interventions

FORTEO DRUG

prescribed in accordance with usual clinical practice for up to 24 months

Also known as: Teriparatide, LY333334

FORTEO (teriparatide)-treated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community sample

You may qualify if:

• Men and women who are judged by the study physician to be suitable for FORTEO therapy. The FORTEO product labeling specifies those individuals diagnosed with osteoporosis who are considered to be at high risk for fracture

You may not qualify if:

• Subjects who have an increased baseline risk for osteosarcoma. These include Paget's disease of bone, pediatric populations and young adult patients with open epiphyses, prior external beam or implant radiation therapy involving the skeleton
• Subjects who have administered FORTEO or PTH therapy for more than two weeks directly before study entry
• Subjects who have completed a course of FORTEO or PTH therapy of at least 18 months duration before study entry

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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.

Lakewood, Colorado, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: August 1, 2003
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 26, 2012
• Results First Posted: June 26, 2012

Record last verified: 2012-05

Locations

US (1)