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Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Teriparatide
Alendronate Sodium
Placebo
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.

Full Information

First Posted
January 13, 2003
Last Updated
February 13, 2009
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00051558
Brief Title
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Official Title
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
428 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
Arm Title
B
Arm Type
Active Comparator
Arm Description
Alendronate 10 mg/day oral plus injection placebo, 36 months
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
LY333334, Forteo, Forsteo
Intervention Description
20 micrograms/day, injection, 36 months
Intervention Type
Drug
Intervention Name(s)
Alendronate Sodium
Intervention Description
10 mg/day, oral, 36 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo, daily, 36 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection placebo, daily, 36 months
Primary Outcome Measure Information:
Title
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Description
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
18 month endpoint
Secondary Outcome Measure Information:
Title
Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Description
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
18 month endpoint
Title
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Description
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
3, 6, 12, 18, 24, 36 months
Title
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Description
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
3, 6, 12, and 18 months
Title
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Description
change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
24 and 36 months and Endpoint at 36 months
Title
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Description
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
18, 24, 36 months, and 18 and 36 month endpoints
Title
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Description
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
18, 24, 36 months, and 18 and 36 month endpoints
Title
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Description
change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
12, 18, 24, and 36 months
Title
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Description
change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
Time Frame
12, 18, 24, and 36 months
Title
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Time Frame
1, 6, 18, and 36 months
Title
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Time Frame
1, 6, 18, and 36 months
Title
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Time Frame
1, 6, 18, and 36 months
Title
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Time Frame
1, 6, 18, and 36 months
Title
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Time Frame
1, 6, 18, and 36 months
Title
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Description
Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Loma Linda
State/Province
California
Country
United States
Facility Name
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
City
Palo Alto
State/Province
California
Country
United States
Facility Name
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
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
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
City
Fargo
State/Province
North Dakota
Country
United States
Facility Name
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
City
Jamestown
State/Province
North Dakota
Country
United States
Facility Name
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
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
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
City
Graz
Country
Austria
Facility Name
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
City
Vienna
Country
Austria
Facility Name
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
City
Brussels
Country
Belgium
Facility Name
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
City
Gent
Country
Belgium
Facility Name
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
City
Leuven
Country
Belgium
Facility Name
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
City
Aarhus
Country
Denmark
Facility Name
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
City
Oslo
Country
Norway
Facility Name
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
City
Carolina
Country
Puerto Rico
Facility Name
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
City
Ponce
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
27111239
Citation
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.
Results Reference
derived
PubMed Identifier
19918047
Citation
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.
Results Reference
derived
PubMed Identifier
18003959
Citation
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.
Results Reference
derived

Learn more about this trial

Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

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