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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Raloxifene
  • 60 mg QD
• Drug: Raloxifene
  • 120 mg QD
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Active Comparator: 2
• Placebo Comparator: 3

Primary Measures

• 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
  • Time Frame: 6 months
    

Secondary Measures

• 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.
  • Time Frame: 6 months
    

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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 Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00532428

Study ID Number: 8149

ClinicalTrials.gov Identifier: NCT00532428

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry