Bone Effects of Teriparatide Following Alendronate

Osteoporosis Clinical Trial

Official title:

Bone Effects of Subcutaneous Teriparatide Following Discontinuation of Alendronate Treatment in Postmenopausal Women With Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191893
• Other study ID #: 7918
• Secondary ID: B3D-VI-GHCK
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 24, 2007
• Start date: September 2003
• Est. completion date: November 2006

Study information

• Verified date: January 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlAustria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• teriparatide

Locations

Country	Name	City	State
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
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Austria,  Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies.
Secondary	BMD (DXA, Holoc Delphi A),Biochemical markers of bone metabolism,3-D bone morphology by high resolution quantitative Computed Tomography (QCT)