A Study for Patients With Osteoporosis
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Teriparatide (Drug); Salmon Calcitonin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
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
Clinical Details
Official title: Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
Secondary outcome: Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal WomenPercentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
Eligibility
Minimum age: 40 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
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 100050, 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 610041, 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 210029, 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 200023, 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 325027, China
Additional Information
Starting date: December 2006
Last updated: October 22, 2009
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