Overview

Bone Effects of Teriparatide Following Alendronate

Status:
Completed
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
Female
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 architecture. Patients will include postmenopausal, osteoporotic women who have been treated long term (at least 36 months) with alendronate, as well as postmenopausal, osteoporotic women who have never been treated for osteoporosis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Alendronate
Teriparatide
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.