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Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis
This study has been completed.
Study NCT00035256   Information provided by Eli Lilly and Company
First Received: May 2, 2002   Last Updated: May 11, 2007   History of Changes

May 2, 2002
May 11, 2007
October 2001
 
The study is designed to compare the effect of 1 year of raloxifene treatment with the effect of placebo on maintaining teriparatide-induced increases in spine and hip BMD.
Same as current
Complete list of historical versions of study NCT00035256 on ClinicalTrials.gov Archive Site
  • An open-label treatment phase will extend the study for 1 year beyond the primary endpoint. During this final year of the study all patients will receive raloxifene.
  • The purpose of lengthening is to assess the differences in response to raloxifene when it is administered immediately following versus 1 year after(with and without a washout period) withdrawal from teriparatide.
Same as current
 
Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis
Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

The purpose of this study is to determine whether the increase in spine bone mineral density that has been generally observed in previous clinical studies involving the study drug can be maintained or even increased if followed with raloxifene HCl. All qualifying study participants will receive the study drug followed by treatment with raloxifene HCl or placebo. All study participants will receive raloxifene HCl in the third phase of the study.

 
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Osteoporosis, Postmenopausal
  • Drug: teriparatide
  • Drug: raloxifene HCl
  • Drug: placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
330
July 2005
 

Inclusion Criteria:

  • Must be diagnosed with osteoporosis
  • Must be female, age 55 through 80
  • Must be at least 5 years postmenopausal
  • Must be free of other severe or chronically disabling conditions
  • Must be able to properly use injection device.

Exclusion Criteria:

  • Must not have bone diseases other than osteoporosis
  • Must not have history of certain cancers
  • Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes)
  • Must not have treatment with particular medications (warfarin, estrogens, androgens, steroids, calcitonins, fluorides, biphosphonates)
  • Must not have known allergy to the study agent or raloxifene HCl
Female
55 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00035256
 
5490, B3D-MC-GHBQ
Eli Lilly and Company
 
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP