Clinical trial NCT00414973: A Study for Patients With Osteoporosis
Official title: Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 364
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women
timeFrame: Baseline to 24 weeks
measure: Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women
timeFrame: Baseline to 12 weeks and 24 weeks
measure: Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men
timeFrame: Baseline to 24 weeks
measure: Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men
timeFrame: Baseline to 24 weeks
measure: Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
timeFrame: Baseline to 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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.
city: Chengdu
country: China
facility: 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.
city: Nanjing
country: China
facility: 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.
city: Shanghai
country: China
facility: 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.
city: Wenzhou
country: China
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: