Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
1 other identifier
interventional
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2006
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedFirst Posted
Study publicly available on registry
September 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedSeptember 16, 2010
September 1, 2010
3.4 years
September 1, 2006
September 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone turnover and bone mineral density
12 months
Secondary Outcomes (1)
Fracture, safety
12 months
Study Arms (2)
1
ACTIVE COMPARATORraloxifene
2
PLACEBO COMPARATORplacebo arm
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tuen Mun Hospitallead
- Eli Lilly and Companycollaborator
Study Sites (1)
Tuen Mun Hospital
Hong Kong, China
Related Publications (1)
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.
PMID: 21187295DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CC MOK, MD, FRCP
Tuen Mun Hospital Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 1, 2006
First Posted
September 4, 2006
Study Start
September 1, 2006
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
September 16, 2010
Record last verified: 2010-09