Status:
COMPLETED
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
Lead Sponsor:
Eli Lilly and Company
Conditions:
Osteoporosis
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone ...
Detailed Description
The study has 3 periods: a screening phase, a double-blind, double-dummy treatment phase from the time of randomization to the 26 weeks visit, and an open-label treatment phase of approximately 12 mon...
Eligibility Criteria
Inclusion
- Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region
- Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men
Exclusion
- Clinically significant abnormal laboratory values
- History of unresolved skeletal diseases that affect bone metabolism
- Polytrauma participants and participants with fractures at more than one site
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00887354
Start Date
April 1 2009
End Date
August 1 2015
Last Update
September 25 2019
Active Locations (28)
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1
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.
Fort Lauderdale, Florida, United States, 33316
2
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.
New Port Richey, Florida, United States, 34652
3
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.
Orlando, Florida, United States, 32804
4
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.
New York, New York, United States, 10075