Raloxifene for Prevention of Bone Loss in Postmenopausal... | NCT00371956

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

NCT00371956

Sponsor

Tuen Mun Hospital

Status

Completed

Last Update Posted

Sep 16, 2010Estimated

Enrollment

114Actual

Phase

Phase 4

Conditions

Osteoporosis

Interventions

raloxifene
placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Sep 1, 2006

First Submission Date that Met QC Criteria

Sep 1, 2006

First Posted Date

Sep 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2010

Last Update Posted Date

Sep 16, 2010Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	raloxifene	Drug: raloxifene
2	Placebo Comparator	placebo arm	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
raloxifene	Drug	60mg/day	1
placebo

Measure	Description	Time Frame
Bone turnover and bone mineral density		12 months

Measure	Description	Time Frame
Fracture, safety		12 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CC MOK, MD, FRCP	Tuen Mun Hospital Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tuen Mun Hospital		Hong Kong			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21187295	Derived	Mok CC, Ying KY, To CH, Ho LY, Yu KL, Lee HK, Ma KM. 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. doi: 10.1136/ard.2010.143453. Epub 2010 Dec 27.

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

ID	Term
D013629	Tamoxifen
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives