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Clinical Trials/NCT00191893
NCT00191893CompletedPhase 3

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

Eli Lilly and Company2 sites in 2 countries66 target enrollmentStarted: September 1, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
66
Locations
2
Primary Endpoint
conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies.

Secondary Outcomes

  • BMD (DXA, Holoc Delphi A),Biochemical markers of bone metabolism,3-D bone morphology by high resolution quantitative Computed Tomography (QCT)

Investigators

Sponsor Class
Industry

Study Sites (2)

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