NCT00557310

Brief Summary

The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2007

Longer than P75 for phase_4

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6 months until next milestone

Results Posted

Study results publicly available

November 11, 2011

Completed
Last Updated

November 11, 2011

Status Verified

October 1, 2011

Enrollment Period

2.9 years

First QC Date

November 9, 2007

Results QC Date

October 7, 2011

Last Update Submit

October 7, 2011

Conditions

Osteoporosis, Postmenopausal

Keywords

osteoporosis, teriparatide, postmenopausal, MRI, finite element analysis

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint

    SCR is a measure of the computed ratio of plate-like to rod-like structures in a given volume of trabecular bone and reflects the integrity of the trabecular network. The higher the value for SCR, the more intact the trabecular network. Least squares (LS) mean of the percent change from baseline to 18 months is from a mixed model repeated measurements analysis. The model included terms for investigator site, prior bisphosphonate use, visit and baseline.

    Baseline, 18 months

Secondary Outcomes (16)

  • Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint

    Baseline, 24 months

  • Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint

    Baseline, 18, 24 months

  • Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint

    Baseline, 18, 24 months

  • Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint

    Baseline, 18, 24 months

  • Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint

    Baseline, 3, 6, 12, 18, 24 months

  • +11 more secondary outcomes

Study Arms (1)

Teriparatide

EXPERIMENTAL

20 micrograms (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Drug: teriparatide

Interventions

teriparatideDRUG

20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Also known as: LY333334, FORTEO, FORSTEO
Teriparatide

Eligibility Criteria

Age45 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal (after the "change of life") women with osteoporosis
  • between the ages of 45-85
  • have low bone mass as determined by a bone density test
  • have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites)
  • could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate

You may not qualify if:

  • have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study
  • have a metal implant or have had a hip replacement in either hip which might affect results of study
  • have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton
  • currently have active or suspected diseases that affect the bone, other than osteoporosis
  • have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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.

Tucson, Arizona, 85704, United States

Location

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, 80227, United States

Location

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.

Omaha, Nebraska, 68131, United States

Location

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.

Albuquerque, New Mexico, 87106, United States

Location

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.

Pittsburgh, Pennsylvania, 15213, United States

Location

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.

Vancouver, British Columbia, V6H 3X8, Canada

Location

Related Links

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino 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
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 14, 2007

Study Start

November 1, 2007

Primary Completion

October 1, 2010

Study Completion

May 1, 2011

Last Updated

November 11, 2011

Results First Posted

November 11, 2011

Record last verified: 2011-10

Locations

US(5)CA(1)