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

Tracking Information

First Received Date ^ICMJE

September 1, 2006

Last Updated Date

May 26, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bone turnover and bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Bone turnover and bone mineral density

Change History

Complete list of historical versions of study NCT00371956 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Fracture, safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Fracture, safety

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-Blind Placebo-Controlled Study

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: raloxifene
Drug: placebo

Study Arms / Comparison Groups

Active Comparator: raloxifene
Placebo Comparator: placebo arm

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00371956

Responsible Party

CC Mok, Tuen Mun Hospital, Hong Kong

Study ID Numbers ^ICMJE

HARECCTR0500058

Study Sponsor ^ICMJE

Tuen Mun Hospital

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

CC MOK, MD, FRCP

Tuen Mun Hospital, Hong Kong

Information Provided By

Tuen Mun Hospital

Verification Date

May 2009

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