NCT00051558

Brief Summary

Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
428

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_3

Geographic Reach
6 countries

15 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, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 13, 2009

Completed
Last Updated

March 12, 2009

Status Verified

February 1, 2009

Enrollment Period

3.7 years

First QC Date

January 13, 2003

Results QC Date

January 14, 2009

Last Update Submit

February 13, 2009

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)

    change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

    18 month endpoint

Secondary Outcomes (14)

  • Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset

    18 month endpoint

  • Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

    3, 6, 12, 18, 24, 36 months

  • Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset

    3, 6, 12, and 18 months

  • Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined

    24 and 36 months and Endpoint at 36 months

  • Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined

    18, 24, 36 months, and 18 and 36 month endpoints

  • +9 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Teriparatide 20 micrograms/day injection plus oral placebo, 36 months

Drug: TeriparatideDrug: Placebo

B

ACTIVE COMPARATOR

Alendronate 10 mg/day oral plus injection placebo, 36 months

Drug: Alendronate SodiumDrug: Placebo

Interventions

TeriparatideDRUG

20 micrograms/day, injection, 36 months

Also known as: LY333334, Forteo, Forsteo
A
Alendronate SodiumDRUG

10 mg/day, oral, 36 months

B
PlaceboDRUG

Oral placebo, daily, 36 months

A

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women age 21 years or older
  • Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening

You may not qualify if:

  • Taking bisphosphonates within past 6 months
  • More than 30 micrograms/day of estradiol or equivalent in past 3 months
  • History of alcoholism or drug abuse in past year
  • Pregnant women or nursing mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Loma Linda, California, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Palo Alto, California, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Aurora, Colorado, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Fargo, North Dakota, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Jamestown, North Dakota, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Milwaukee, Wisconsin, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Graz, Austria

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Vienna, Austria

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Brussels, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Ghent, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Leuven, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Aarhus, Denmark

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Oslo, Norway

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Carolina, Puerto Rico

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Ponce, Puerto Rico

Location

Related Publications (3)

  • Saag KG, Agnusdei D, Hans D, Kohlmeier LA, Krohn KD, Leib ES, MacLaughlin EJ, Alam J, Simonelli C, Taylor KA, Marcus R. Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide. Arthritis Rheumatol. 2016 Sep;68(9):2122-8. doi: 10.1002/art.39726.

    PMID: 27111239DERIVED

  • Devogelaer JP, Adler RA, Recknor C, See K, Warner MR, Wong M, Krohn K. Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis. J Rheumatol. 2010 Jan;37(1):141-8. doi: 10.3899/jrheum.090411. Epub 2009 Nov 16.

    PMID: 19918047DERIVED

  • Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. doi: 10.1056/NEJMoa071408.

    PMID: 18003959DERIVED

Related Links

MeSH Terms

Conditions

Osteoporosis

Interventions

TeriparatideAlendronate

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 ProteinsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
1-800-545-5979

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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2003

First Posted

January 14, 2003

Study Start

November 1, 2002

Primary Completion

July 1, 2006

Study Completion

January 1, 2008

Last Updated

March 12, 2009

Results First Posted

February 13, 2009

Record last verified: 2009-02

Locations

NO(1)PR(2)US(6)BE(3)DK(1)AU(2)