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
  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
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
raloxifene
Drug: raloxifene
60mg/day
Placebo Comparator: 2
placebo arm
Drug: placebo
tab 1 daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Tuen Mun Hospital

Additional 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:
raloxifene
estrogen
receptor
modulation
osteoporosis
steroid
Steroids

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

ClinicalTrials.gov processed this record on September 30, 2014