Bone Effects of Teriparatide Following Alendronate
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: teriparatide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
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.
Clinical Details
Official title: Bone Effects of Subcutaneous Teriparatide Following Discontinuation of Alendronate Treatment in Postmenopausal Women With Osteoporosis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies.
Secondary outcome: BMD (DXA, Holoc Delphi A),Biochemical markers of bone metabolism,3-D bone morphology by high resolution quantitative Computed Tomography (QCT)
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
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 A-8010, Austria
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, Praha 12808, Czech Republic
Additional Information
Starting date: September 2003
Last updated: January 24, 2007
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