Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00532545
First received: September 18, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted

September 18, 2007
September 18, 2007
April 2003
Not Provided
To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, is able to produce reliable changes in the bone marker in a severe osteoporotic population in Puerto Rico.
Same as current
No Changes Posted
  • To test the hypothesis that this group of patients will have a high score in the survey used by IOF as an instrument to check risk factors.
  • Test the hypothesis that patients will have a high score in the survey used by IOF as an instrument to check risk factors.
Same as current
Not Provided
Not Provided
 
Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis
Bone Marker Changes In One Month Treatment With TERIPARATIDE (LY333334) Injections (rDNA Origin) in Men and Postmenopausal Women With Severe Osteoporosis

To test the hypothesis that Teriparatide injections given 20 micrograms/daily subcutaneously, for one month, are able to produce reliable changes in the bone marker in a severe osteoporotic population

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis, Post-Menopausal
Drug: Teriparatide
Teriparatide 20 micrograms/daily subcutaneously
Other Name: LY333334
Experimental: A
Teriparatide
Intervention: Drug: Teriparatide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
April 2004
Not Provided

Inclusion Criteria:

  • Presents with severe osteoporosis based on the disease diagnostic criteria and upon physician assessment
  • Postmenopausal, nonpregnant, women older than 50 years of age, with previous fracture history such as hip, spine, wrist, ribs, clavicle, humerus, tibia, and fibula or men over 50 years of age with low impact fractures (fragility).
  • Outpatients without concomitant diseases and with life expectancy of at least 3 years, according to the medical criteria.
  • Cannot be on medicines that can disturb bone metabolism.
  • Patients should be capable of self-injection, to learn the use of Pen device and are in agreement with its use.

Exclusion Criteria:

  • Directly affiliated with the conduct of this study, or are the immediate family of someone directly affiliated with the conduct of this study (that is, Lilly employees, investigators, site personnel, or their immediate families). Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
  • Received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry.
  • Previously completed or withdrawn from this study or any other study investigating Teriparatide.
  • Secondary osteoporosis or any disease that affects the bone metabolism, as renal osteodystrophy, osteomalacia, hypoparathyroidism, and hyperparathyroidism, and intestinal malabsorption.
  • Cancer history in the 5 years prior to visit 1, with exemption of basocellular carcinoma treated and cervix carcinoma definitively treated at least 1 year before to visit 1
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT00532545
6715, B3D-SU-S001
No
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2007

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