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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371956
First Posted: September 4, 2006
Last Update Posted: September 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by:
Tuen Mun Hospital
  Purpose
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.

Condition Intervention Phase
Osteoporosis Drug: raloxifene Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Tuen Mun Hospital:

Primary Outcome Measures:
  • Bone turnover and bone mineral density [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Fracture, safety [ Time Frame: 12 months ]

Enrollment: 114
Study Start Date: September 2006
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
raloxifene
Drug: raloxifene
60mg/day
Placebo Comparator: 2
placebo arm
Drug: placebo
tab 1 daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 <= 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371956


Locations
China
Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Tuen Mun Hospital
Eli Lilly and Company
Investigators
Principal Investigator: CC MOK, MD, FRCP Tuen Mun Hospital, Hong Kong
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CC Mok, Tuen Mun Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT00371956     History of Changes
Other Study ID Numbers: HARECCTR0500058
First Submitted: September 1, 2006
First Posted: September 4, 2006
Last Update Posted: September 16, 2010
Last Verified: September 2010

Keywords provided by Tuen Mun Hospital:
raloxifene
estrogen
receptor
modulation
osteoporosis
steroid
Steroids

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Raloxifene Hydrochloride
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents