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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

NCTNCT00051558 (opens ClinicalTrials.gov in a new tab)Other id6484Other idB3D-US-GHBZ
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
428 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Quadruple masking
Countries
6 countries

United States, Austria, Belgium, Denmark, Norway, Puerto Rico

Start
Nov 2002
Primary completion
Jul 2006
Completion
Jan 2008
First posted
14 Jan 2003 (estimated)
Last update posted
12 Mar 2009 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2002200420062008
  1. Ph 3

    Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

    NCT00051558

    Nov 2002 to Jan 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug
  • Alendronate SodiumDrug
  • PlaceboDrug
  • PlaceboDrug

Arms2

  • Experimental

    A

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

  • Active comparator

    B

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 18 month endpoint

    Registry description

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

Secondary outcomes(14)

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

    Time frame · 18 month endpoint

    Registry description

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

  2. 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

    Registry description

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

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

    Time frame · 3, 6, 12, and 18 months

    Registry description

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

  4. 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

    Registry description

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

  5. 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

    Registry description

    change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)

  6. 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

    Registry description

    change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)

  7. 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

    Registry description

    change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)

  8. 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

    Registry description

    change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)

  9. 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

  10. 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

  11. 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

  12. 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

  13. Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin

    Time frame · 1, 6, 18, and 36 months

  14. Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures

    Time frame · 36 months

    Registry description

    Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 18 month endpoint

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

GroupValue (grams per square centimeters)Spread
Teriparatide0.0590.006
Alendronate0.0280.006
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· 18 month endpoint

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

GroupValue (grams per square centimeters)Spread
Teriparatide0.0560.006
Alendronate0.0230.006
Secondary outcomeLeast squares mean· 3, 6, 12, 18, 24, 36 months

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

GroupValue (grams per square centimeters)Spread
Teriparatide0.0900.006
Alendronate0.0440.007
Secondary outcomeLeast squares mean· 3, 6, 12, and 18 months

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

GroupValue (grams per square centimeters)Spread
Teriparatide0.0620.005
Alendronate0.0270.005
Secondary outcomeLeast squares mean· 24 and 36 months and Endpoint at 36 months

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

GroupValue (grams per square centimeters)Spread
Teriparatide0.0730.008
Alendronate0.0340.008
Secondary outcomeLeast squares mean· 18, 24, 36 months, and 18 and 36 month endpoints

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

GroupValue (grams per square centimeters)Spread
Teriparatide0.0330.006
Alendronate0.0170.006
Secondary outcomeLeast squares mean· 18, 24, 36 months, and 18 and 36 month endpoints

Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined

GroupValue (grams per square centimeters)Spread
Teriparatide0.0320.005
Alendronate0.0170.005
Secondary outcomeLeast squares mean· 12, 18, 24, and 36 months

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

GroupValue (grams per square centimeters)Spread
Teriparatide0.0410.005
Alendronate0.0210.005

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
TeriparatideTeriparatide 20 micrograms/day injection plus oral placebo, 36 months–70 / ?190 / ?
AlendronateAlendronate 10 mg/day oral plus injection placebo, 36 months–64 / ?177 / ?

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2016

2 results

Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide.

Saag et al. 2016Arthritis & rheumatology (Hoboken, N.J.)cited by 68

PMID 27111239DOI 10.1002/art.39726PUB-27111239

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2010

4 results

Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis.

Devogelaer et al. 2010The Journal of rheumatologycited by 46

PMID 19918047DOI 10.3899/jrheum.090411PUB-19918047

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2007

5 results

Teriparatide or alendronate in glucocorticoid-induced osteoporosis.

Saag et al. 2007The New England journal of medicinecited by 569

PMID 18003959DOI 10.1056/nejmoa071408PUB-18003959

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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