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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

364

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2006

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

December 1, 2006

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

August 26, 2009

Completed

Last Updated

October 28, 2009

Status Verified

October 1, 2009

Enrollment Period

1.6 years

First QC Date

December 20, 2006

Results QC Date

July 16, 2009

Last Update Submit

October 22, 2009

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
Baseline to 24 weeks

Secondary Outcomes (5)

Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women
Baseline to 24 weeks
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women
Baseline to 12 weeks and 24 weeks
Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men
Baseline to 24 weeks
Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men
Baseline to 24 weeks
Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
Baseline to 12 weeks and 24 weeks

Study Arms (2)

A

EXPERIMENTAL

Drug: Teriparatide

B

ACTIVE COMPARATOR

Drug: Salmon Calcitonin

Interventions

TeriparatideDRUG

Subcutaneous, 20 micrograms/day, 24 weeks

Also known as: LY333334, Forteo, Forsteo

Salmon CalcitoninDRUG

Intranasal, 200 International Units (IU)/day, 24 weeks

Eligibility Criteria

Age40 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (5)

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

Location

Chengdu, 610041, China

Location

Nanjing, 210029, China

Location

Shanghai, 200023, China

Location

Wenzhou, 325027, China

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatidesalmon calcitonin

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 20, 2006

First Posted

December 22, 2006

Study Start

December 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 28, 2009

Results First Posted

August 26, 2009

Record last verified: 2009-10

Locations

CN(5)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations