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Clinical Trials/NCT00079924
NCT00079924CompletedPhase 4

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

Eli Lilly and Company10 sites in 1 country200 target enrollmentStarted: November 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
200
Locations
10
Primary Endpoint
Change in calcium values after beginning teriparatide
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in calcium values after beginning teriparatide

Secondary Outcomes

  • Frequency of hypercalcemia, various calcium assessments, change in bone mineral density and tests of bone formation and resorption

Investigators

Sponsor Class
Industry

Study Sites (10)

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