A Study for Patients With Osteoporosis

Osteoporosis Clinical Trial

Official title:

Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414973
• Other study ID #: 10591
• Secondary ID: B3D-MC-GHDG
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2006
• Last updated: October 22, 2009
• Start date: December 2006
• Est. completion date: July 2008

Study information

• Verified date: October 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Teriparatide
Subcutaneous, 20 micrograms/day, 24 weeks
• Salmon Calcitonin
Intranasal, 200 International Units (IU)/day, 24 weeks

Locations

Country	Name	City	State
China	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.	Beijing
China	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.	Chengdu
China	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.	Nanjing
China	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.	Shanghai
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women		Baseline to 24 weeks	No
Secondary	Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women		Baseline to 24 weeks	No
Secondary	Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women		Baseline to 12 weeks and 24 weeks	No
Secondary	Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men		Baseline to 24 weeks	No
Secondary	Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men		Baseline to 24 weeks	No
Secondary	Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men		Baseline to 12 weeks and 24 weeks	No