A Study for Patients With Osteoporosis - Full Text View

Purpose

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

Condition	Intervention	Phase
Osteoporosis	Drug: Teriparatide Drug: Salmon Calcitonin	Phase III

MedlinePlus related topics:

Osteoporosis

ChemIDplus related topics:

Teriparatide Teriparatide acetate Calcitonin Calcitonin human Fortical

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Lumbar spine BMD, postmenopausal women. [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total hip BMD, postmenopausal women [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
Osteocalcin, postmenopausal women at 12 and 24 weeks [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
Safety (physical examination, vital signs, clinical laboratory data and adverse events) at 24 weeks [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
Lumbar spine BMD, men [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
Total hip BMD, men [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
Osteocalcin, men [ Time Frame: 12 weeks, 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	364
Study Start Date:	December 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Teriparatide Subcutaneous, 20 micrograms/day, 24 weeks
B: Active Comparator	Drug: Salmon Calcitonin Intranasal, 200 IU/day, 24 weeks

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414973

Locations


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, 100050
	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, 610041
	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, 210029
	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, 200023
	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, 325027

Sponsors and Collaborators

Eli Lilly and Company

Investigators


Study Director:	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)	Eli Lilly and Company

More Information

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10591, B3D-MC-GHDG
First Received:	December 20, 2006
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00414973
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Calcitonin Gene-Related Peptide

Calcitonin

Musculoskeletal Diseases

Teriparatide

Osteoporosis

Bone Diseases, Metabolic

Salmon calcitonin

Bone Diseases

Additional relevant MeSH terms:

Vasodilator Agents

Therapeutic Uses

Physiological Effects of Drugs

Bone Density Conservation Agents

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00414973