OsteoporosisPhase 3NCT00051558

Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

A Phase 3 study testing Teriparatide and Alendronate Sodium in people with Osteoporosis, run by Eli Lilly and Company at 15 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Osteoporosis
What is being tested?: Teriparatide and Alendronate Sodium
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 428 participants
Where: 15 sitesin 6 countries
Study dates: Nov 2002to Jan 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

15 sites in 6 countries.

Country

City, postcode or hospital

15 sites in 6 countries

United States6 sites

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
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
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
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
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
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

Other trials in United States

Belgium3 sites

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
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
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

Other trials in Belgium

Austria2 sites

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
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

Other trials in Austria

Puerto Rico2 sites

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
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

Other trials in Puerto Rico

Denmark1 site

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

Other trials in Denmark

Norway1 site

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

Other trials in Norway

About this study

Official title: Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis

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.

Conditions: Osteoporosis
Being tested: Teriparatide, Alendronate Sodium, Placebo
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TeriparatideDrug
Also called LY333334, Forteo, Forsteo
20 micrograms/day, injection, 36 months
Alendronate SodiumDrug
10 mg/day, oral, 36 months
PlaceboDrug
Oral placebo, daily, 36 months
PlaceboDrug
Injection placebo, daily, 36 months

Study groups in NCT00051558
Study group	Role	What they receive
A	Experimental	Teriparatide 20 micrograms/day injection plus oral placebo, 36 months Receives: Drug: Teriparatide; Drug: Placebo
B	Active comparator	Alendronate 10 mg/day oral plus injection placebo, 36 months Receives: Drug: Alendronate Sodium; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 18 month endpoint

Secondary outcomes (14)

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)
Measured: 18 month endpoint
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)
Measured: 3, 6, 12, 18, 24, 36 months
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)
Measured: 3, 6, 12, and 18 months
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)
Measured: 24 and 36 months and Endpoint at 36 months
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)
Measured: 18, 24, 36 months, and 18 and 36 month endpoints
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)
Measured: 18, 24, 36 months, and 18 and 36 month endpoints
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)
Measured: 12, 18, 24, and 36 months
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)
Measured: 12, 18, 24, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
Measured: 1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
Measured: 1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
Measured: 1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
Measured: 1, 6, 18, and 36 months
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Measured: 1, 6, 18, and 36 months
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.
Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2002Jan 2008

First posted14 Jan 2003 (estimated)
Study startNov 2002
Primary completionJul 2006
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 428 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00051558
Sponsor's protocol ID: 6484
Other IDs: B3D-US-GHBZ
Status last verified: Feb 2009
First submitted: 13 Jan 2003
Last updated: 12 Mar 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27111239
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.
PubMed 19918047
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.
PubMed 18003959

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
ClinicalTrials.gov ID: NCT00051558
Acronym / sponsor ID: 6484
Conditions: Osteoporosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 428 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2002
Primary completion: Jul 2006 (actual)
Study completion: Jan 2008 (actual)
First posted: 14 Jan 2003 (estimated)
Results: Posted 13 Feb 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Teriparatide, Drug: PlaceboTeriparatide 20 micrograms/day injection plus oral placebo, 36 months
B	Active comparator	Drug: Alendronate Sodium, Drug: PlaceboAlendronate 10 mg/day oral plus injection placebo, 36 months

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TeriparatideAlso: LY333334, Forteo, Forsteo20 micrograms/day, injection, 36 months	Drug	A
Alendronate Sodium10 mg/day, oral, 36 months	Drug	B
PlaceboOral placebo, daily, 36 months	Drug	A
PlaceboInjection placebo, daily, 36 months	Drug	B

Primary outcome

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
Time frame: 18 month endpoint
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)

14 secondary outcomes

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Time frame: 18 month endpoint
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Time frame: 3, 6, 12, 18, 24, 36 months
Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
Time frame: 3, 6, 12, and 18 months
Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
Time frame: 24 and 36 months and Endpoint at 36 months
Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Time frame: 18, 24, 36 months, and 18 and 36 month endpoints
Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Time frame: 18, 24, 36 months, and 18 and 36 month endpoints
Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
Time frame: 12, 18, 24, and 36 months
Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
Time frame: 12, 18, 24, and 36 months
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
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
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
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
Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
Time frame: 1, 6, 18, and 36 months
Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
Time frame: 36 months

Results and safety

Results posted to the registry on 13 Feb 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Teriparatide	214	123
Alendronate	214	118

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

Time frame: 18 month endpoint. Least squares mean (Standard Error). Unit: grams per square centimeters

Measure	Teriparatide n = 198	Alendronate n = 195
Value	0.059 (0.006)	0.028 (0.006)

Teriparatide vs Alendronate: p <0.001, ANOVA

Population analysed: The intention-to-treat analysis was performed using all randomized and treated patients.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Teriparatide	70 of ?	190 of ?	Not reported
Alendronate	64 of ?	177 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27111239Saag 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.
Derived from this study: PubMed 19918047Devogelaer 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.
Derived from this study: PubMed 18003959Saag 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.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
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Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

15 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Teriparatide and Alendronate Sodium in people with Osteoporosis, run by Eli Lilly and Company at 15 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Belgium, Austria, Puerto Rico, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Feb 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD) (time frame: 18 month endpoint). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00051558, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2009.