Bone Effects of Teriparatide Following Alendronate
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191893
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: teriparatide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Bone Effects of Subcutaneous Teriparatide Following Discontinuation of Alendronate Treatment in Postmenopausal Women With Osteoporosis |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies.
Secondary Outcome Measures:
- BMD (DXA, Holoc Delphi A),Biochemical markers of bone metabolism,3-D bone morphology by high resolution quantitative Computed Tomography (QCT)
| Estimated Enrollment: | 66 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | November 2006 |
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191893
Locations
| 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 | |
| Graz, Austria, A-8010 | |
| Czech Republic | |
| 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, Czech Republic, 12808 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00191893 History of Changes |
| Other Study ID Numbers: | 7918, B3D-VI-GHCK |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| Health Authority: | Czech Republic: State Institute for Drug Control Austria: Federal Ministry for Health and Women |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Alendronate |
Teriparatide Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013