Bone Marker Changes With Teriparatide/Postmenopausal Osteoporosis
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis, Post-Menopausal
Intervention: Teriparatide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): 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), Study Director, Affiliation: Eli Lilly and Company
Summary
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
Clinical Details
Official title: Bone Marker Changes In One Month Treatment With TERIPARATIDE (LY333334) Injections (rDNA Origin) in Men and Postmenopausal Women With Severe Osteoporosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
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., Bayamon, Puerto Rico
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., Caguas, Puerto Rico
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., Carolina, Puerto Rico
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., Fajardo, Puerto Rico
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., Humacao, Puerto Rico
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., Ponce, Puerto Rico
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., San Juan, Puerto Rico
Additional Information
Lilly Clinical Trial Registry
Starting date: April 2003
Last updated: September 18, 2007
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