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Completed

NCT Number: NCT00051558

Comparison of Teriparatide With Alendronate for Treating 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary 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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

20 micrograms/day, injection, 36 months

Other names: LY333334, Forteo, Forsteo

Alendronate sodium

Drug

10 mg/day, oral, 36 months

Placebo

Drug

Oral placebo, daily, 36 months

Primary outcomes

  1. 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)

Secondary outcomes

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

    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)

  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

    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

    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

    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

    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

    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

    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

    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

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2008
First posted
Jan 14, 2003
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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