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A Study for Patients With Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00414973
First received: December 20, 2006
Last updated: October 22, 2009
Last verified: October 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women [ Time Frame: Baseline to 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men [ Time Frame: Baseline to 12 weeks and 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
Experimental: A Drug: Teriparatide
Subcutaneous, 20 micrograms/day, 24 weeks
Other Names:
  • LY333334
  • Forteo
  • Forsteo
Active Comparator: B Drug: Salmon Calcitonin
Intranasal, 200 International Units (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

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00414973     History of Changes
Other Study ID Numbers: 10591, B3D-MC-GHDG
Study First Received: December 20, 2006
Results First Received: July 16, 2009
Last Updated: October 22, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Salmon calcitonin
Calcitonin
Teriparatide
 Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013