Bone Effects of Teriparatide Following Alendronate

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teriparatide

Drug

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)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2006
First posted: Sep 19, 2005
Registry last updated: Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed