Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis

Eli Lilly and Company1 site in 1 country207 target enrollmentJanuary 2007

ConditionsOsteoporosis

InterventionsTeriparatide Placebo

DrugsTeriparatide Placebo

Overview

Phase: Phase 3
Intervention: Teriparatide
Conditions: Osteoporosis
Sponsor: Eli Lilly and Company
Enrollment: 207
Locations: 1
Primary Endpoint: Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

September 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Japanese patients diagnosed with osteoporosis
•Aged 55 or older
•Patients who are at high risk for fracture

Exclusion Criteria

•History of metabolic bone disorders other than primary osteoporosis
•History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
•Severe or chronically disabling conditions other than osteoporosis

Arms & Interventions

Teriparatide

20 micrograms for 104 weeks

Intervention: Teriparatide

Placebo

Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks

Intervention: Teriparatide

Placebo

Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)

Time Frame: Baseline to 52 weeks

Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.

Secondary Outcomes

Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)(Baseline to 52 Weeks)
Percent Change in Bone Mineral Density (BMD) at Total Hip(Baseline to 52 Weeks)
Percent Change in Bone Mineral Density (BMD) at Femoral Neck(Baseline to 52 Weeks)
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)(Baseline to Weeks 4, 12, 24, and 52)
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)(Baseline to Weeks 4, 12, 24, 52)
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)(Baseline to Weeks 4, 12, 24, 52)
Vertebral Fractures by Central X-ray Assessment(Baseline through 52 weeks)
Fractures by Investigators Assessment(Baseline through 52 Weeks)
Back Pain Severity(Baseline, Weeks 12, 24, 36, 52)
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks(Baseline through 104 Weeks)
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks(Baseline Through 104 Weeks)
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks(Baseline, 76 Weeks, 104 Weeks)