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Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Tuen Mun Hospital
ClinicalTrials.gov Identifier:
NCT00371956
First received: September 1, 2006
Last updated: September 15, 2010
Last verified: September 2010
History of Changes

September 1, 2006
September 15, 2010
September 2006
February 2010   (final data collection date for primary outcome measure)
Bone turnover and bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Bone turnover and bone mineral density
Complete list of historical versions of study NCT00371956 on ClinicalTrials.gov Archive Site
Fracture, safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Fracture, safety
Not Provided
Not Provided
 
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Drug: raloxifene
    60mg/day
  • Drug: placebo
    tab 1 daily
  • Active Comparator: 1
    raloxifene
    Intervention: Drug: raloxifene
  • Placebo Comparator: 2
    placebo arm
    Intervention: Drug: placebo
Mok CC, Ying KY, To CH, Ho LY, Yu KL, Lee HK, Ma KM. Extended report: 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. Epub 2010 Dec 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
February 2010
February 2010   (final data collection date for primary outcome measure)

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 <= 10 mg/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 >= 200 umol/L.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00371956
HARECCTR0500058
Yes
CC Mok, Tuen Mun Hospital, Hong Kong
Tuen Mun Hospital
Eli Lilly and Company
Principal Investigator: CC MOK, MD, FRCP Tuen Mun Hospital, Hong Kong
Tuen Mun Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP