Back to resultsRaloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
raloxifene
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring raloxifene, estrogen, receptor, modulation, osteoporosis, steroid, Steroids
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
- Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone <= 10 mg/day or equivalent).
- Baseline bone mineral density (BMD) of the lumbar spine T score < -1.0.
Exclusion Criteria:
- Patients with a history of thromboembolism.
- Patients with positive antiphospholipid antibodies.
- History of allergic reactions or intolerance to raloxifene or other SERMs.
- Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- Patients with abnormal uterine bleeding of unknown etiology.
- Patients with serum creatinine level of >= 200 umol/L.
Sites / Locations
- Tuen Mun Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
raloxifene
placebo arm
Outcomes
Primary Outcome Measures
Bone turnover and bone mineral density
Secondary Outcome Measures
Fracture, safety
Full Information
NCT ID
NCT00371956
First Posted
September 1, 2006
Last Updated
September 15, 2010
Sponsor
Tuen Mun Hospital
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00371956
Brief Title
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
Official Title
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tuen Mun Hospital
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
raloxifene, estrogen, receptor, modulation, osteoporosis, steroid, Steroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
raloxifene
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo arm
Intervention Type
Drug
Intervention Name(s)
raloxifene
Intervention Description
60mg/day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
tab 1 daily
Primary Outcome Measure Information:
Title
Bone turnover and bone mineral density
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Fracture, safety
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.
Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone <= 10 mg/day or equivalent).
Baseline bone mineral density (BMD) of the lumbar spine T score < -1.0.
Exclusion Criteria:
Patients with a history of thromboembolism.
Patients with positive antiphospholipid antibodies.
History of allergic reactions or intolerance to raloxifene or other SERMs.
Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.
Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
Patients with abnormal uterine bleeding of unknown etiology.
Patients with serum creatinine level of >= 200 umol/L.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CC MOK, MD, FRCP
Organizational Affiliation
Tuen Mun Hospital Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
21187295
Citation
Mok CC, Ying KY, To CH, Ho LY, Yu KL, Lee HK, Ma KM. Raloxifene for prevention of glucocorticoid-induced bone loss: a 12-month randomised double-blinded placebo-controlled trial. Ann Rheum Dis. 2011 May;70(5):778-84. doi: 10.1136/ard.2010.143453. Epub 2010 Dec 27.
Results Reference
derived
Learn more about this trial
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
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