A Study for Patients With Osteoporosis

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Teriparatide; Drug: Salmon Calcitonin

• Registration Number: NCT00414973
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-20
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-22
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-16
• Results First Submitted QC: 2009-07-16
• Results First Posted: 2009-08-26
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-22
• Last Update Posted: 2009-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

• Clinical diagnosis of osteoporosis
• No other severe disabling conditions
• Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5
• Ambulatory
• Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years)

Exclusion Criteria

• History of a disease that affects bone metabolism
• History of treatment with any drug that may significantly affect bone metabolism
• History or presence of liver disease
• History or presence of kidney disease
• History of excessive alcohol drinking or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Teriparatide	-
B	Salmon Calcitonin	-

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women	Baseline to 24 weeks	Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women	Baseline to 24 weeks	Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women	Baseline to 12 weeks and 24 weeks	Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men	Baseline to 24 weeks	Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men	Baseline to 24 weeks	Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men	Baseline to 12 weeks and 24 weeks	Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇨🇳 Wenzhou, China