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Birmingham, Alabama

  • Postmenopausal Osteoporosis

Purpose:

Effects of Teriparatide in Postmenopausal Women Previously Treated with Alendronate or Raloxifene.


Criteria:

Inclusion Criteria: - Postmenopausal women aged at least 50 years - A previous clinical diagnosis of osteoporosis - At high risk for fracture - Current therapy for at least 18 months prior to study entry with either raloxifene HCl or alendronate Na Exclusion Criteria: - History of metabolic bone disease other than osteoporosis - History of malignant neoplasm within the last 5 years except for superficial basal cell carcinoma or squamous cell carcinoma


Study is Available At:


Original ID:

8141


NCT ID:

NCT00079924


Secondary ID:

B3D-MC-GHCM


Study Acronym:


Brief Title:

Effects of Teriparatide in Postmenopausal Women With Osteoporosis


Official Title:

Effects of Teriparatide in Postmenopausal Women With Osteoporosis Previously Treated With Alendronate or Raloxifene


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

50 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:


Overall Contact Information

Official Name:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company

Study Dates

Start Date:November 2004
Completion Date:May 2007
Completion Type:Actual
Verification Date:May 2007
Last Changed Date:May 23, 2007
First Received Date:March 18, 2004

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Frequency of hypercalcemia, various calcium assessments, change in bone mineral density and tests of bone formation and resorption
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in calcium values after beginning teriparatide
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:teriparatide
Intervention Type:Drug
Name:aldrenodate
Intervention Type:Drug
Name:raloxifene

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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