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

This study has been completed.
Eli Lilly and Company
Information provided by:
Tuen Mun Hospital
ClinicalTrials.gov Identifier:
First received: September 1, 2006
Last updated: September 15, 2010
Last verified: September 2010
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
Drug: raloxifene
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fracture, safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
Drug: raloxifene
Placebo Comparator: 2
placebo arm
Drug: placebo
tab 1 daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00371956

Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Tuen Mun Hospital
Eli Lilly and Company
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 
Study First Received: September 1, 2006
Last Updated: September 15, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Tuen Mun Hospital:

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

ClinicalTrials.gov processed this record on May 23, 2016