Status:
COMPLETED
Bone Effects of Teriparatide Following Alendronate
Lead Sponsor:
Eli Lilly and Company
Conditions:
Osteoporosis
Eligibility:
FEMALE
55+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the effect of 24 months of treatment with once daily teriparatide injection (recombinant human PTH \[1-34\]) 20 micrograms on bone histomorphometry and architect...
Eligibility Criteria
Inclusion
- Diagnosis of Osteoporosis: Pretreated patients currently osteoporotic or osteopenic. Treatment-naive patients currently osteoporotic
- Pretreated patients will have had at least 36 months of treatment with alendronate Na 10 mg/day or 70 mg/week. Treatment-naive patients will have no significant osteoporosis treatment in the prior 36 months, as assessed by the investigator
Exclusion
- History of bone metabolic diseases, Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption.
- History of malignant neoplasms in the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00191893
Start Date
September 1 2003
End Date
November 1 2006
Last Update
January 26 2007
Active Locations (2)
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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
Graz, Austria, A-8010
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
Prague, Czechia, 12808