Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
Information source: Tuen Mun Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: raloxifene (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Tuen Mun Hospital Official(s) and/or principal investigator(s):
CC MOK, MD, FRCP, Principal Investigator, Affiliation: Tuen Mun Hospital, Hong Kong
Overall contact:
CC MOK, MD, FRCP, Email: ccmok2006@gmail.com
Summary
Raloxifene for prevention of bone loss in postmenopausal patients receiving chronic
corticosteroid therapy: a randomized double-blind placebo-controlled study
Clinical Details
Official title: Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-Blind Placebo-Controlled Study
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Bone turnover and bone mineral density
Secondary outcome: Fracture, safety
Detailed description:
A double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the
prevention of bone mineral density loss in patients receiving long term corticosteroids
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Postmenopausal patients with various chronic rheumatic diseases receiving chronic
steroid therapy
2. Stable disease for at least 6 months prior to study with a stable dose of steroid
(prednisone <=10mg/day or equivalent).
3. Baseline bone mineral density (BMD) of the lumbar spine T score <-1. 0.
Exclusion Criteria:
1. Patients with a history of thromboembolism.
2. Patients with positive antiphospholipid antibodies
3. History of allergic reactions or intolerance to raloxifene or other SERMs.
4. Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or
anti-cytokine therapies within 6 months prior to study entry.
5. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and
hyperparathyroidism.
6. Patients with abnormal uterine bleeding of unknown etiology.
7. Patients with serum creatinine level of >= 200umol/L.
Locations and Contacts
CC MOK, MD, FRCP, Email: ccmok2006@gmail.com
Tuen Mun Hospital, Hong Kong, China; Recruiting
CC MOK, MD, FRCP, Email: ccmok2006@gmail.com
CC Mok, MD, FRCP, Principal Investigator
Additional Information
Starting date: September 2006
Ending date: November 2009
Last updated: May 2, 2008
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