Long Term Effects of Raloxifene Treatment on Bone Quality
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: Raloxifene (Drug); Raloxifene (Drug); Placebo (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
This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of
long-term treatment with raloxifene on histomorphometry and bone quality in patients who
participated in the Continuing Outcomes Relevant to Evista Study.
Clinical Details
Official title: Long-Term Effects of Raloxifene Treatment on Bone Quality: A Cross-Sectional Study of Postmenopausal Women With Osteoporosis Previously Enrolled in the Continuing Outcomes Relevant to Evista Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To determine the histomorphometric effects on bone,by iliac crest bone biopsy, of long-term (7 &8 yrs) therapy with raloxifene or placebo in postmenopausal women with osteoporosis who were enrolled in the CORE trial
Secondary outcome: Find effect of long-term treatment with raloxifene or placebo on bone quality. Primary measures: primary mineralization defect absence, mean degree of mineralization of bone tissue, absence of woven bone, microCT, microcrack & nanoindentation analysis.
Eligibility
Minimum age: 55 Years.
Maximum age: 85 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Have completed the CORE protocol within 3 months (90 days) prior to study entry and
enrollment.
- Have taken randomized study material for at least 7 years since enrollment in the
MORE protocol. If the patient opted not to receive randomized study material for a
period of 6 months at any point during either the MORE or CORE protocol, this period
must have occurred in its entirety before Visit 3 of the CORE protocol.
- Overall, were at least 75% compliant with randomized study material during the MORE
and CORE protocols.
Exclusion Criteria:
- Have an allergy or other intolerance to tetracycline hydrochloride that would
preclude its administration in conjunction with the bone biopsy procedures. If the
patient is not allergic to all tetracyclines, then this exclusion may be waived by
the sponsor and a different tetracycline to which the patient is not allergic may be
used.
- Have undergone two previous transiliac bone biopsies (one in each iliac crest).
Patients with one previous transiliac bone biopsy are eligible provided that the new
sample is obtained from the contralateral iliac crest.
- In the opinion of the investigator, have any medical or anatomical condition that
potentially could put the patient at additional risk of an adverse event due to the
procedure (for example, coagulation abnormality, extreme obesity, etc.).
- Have a history of bone metabolic diseases, Paget's disease, renal osteodystrophy,
osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism
(uncorrected), and intestinal malabsorption.
- Have a 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.
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., Mexico City, Mexico
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., Amsterdam, Netherlands
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., Barcelona, Spain
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., Granada, Spain
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., Oviedo, Spain
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., Indianapolis, Indiana, United States
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., Omaha, Nebraska, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: April 2003
Last updated: September 18, 2007
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