Risedronate vs Raloxifene in Hormone Replacement Therapy Discontinuation

January 10, 2011 updated by: Sanofi

An 18-Month, Multicenter, Parallel-Group Study to Determine The Relative Efficacy of Risedronate Versus Raloxifene in Subjects Who Have Discontinued Hormone Replacement Therapy (HRT) for Early Intervention in Osteoporosis

This is a multi-center, randomized, double-blind, double-dummy study designed to compare the effects of risedronate, raloxifene, and placebo on BMD, bone turnover markers, and other markers of anabolic activity in postmenopausal women who previously received HRT.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal, ambulatory females, "postmenopausal" defined as the absence of menses for at least 12 continuous months)
  • In general good health as determined by medical history, physical examination, and laboratory tests
  • LS spine BMD T-score between -1.0 and -2.4, inclusive
  • At least one analyzable BMD site at both the hip (left or right) and LS spine (at least 3 measurable lumbar spine vertebrae, without fracture or sufficient degenerative disease)
  • Currently receiving no medications for the treatment or prevention of osteoporosis
  • Had been on continuous HRT for at least 1 year prior to enrollment. The HRT must have ended within 18 months prior to the baseline visit, and the subject must have been off HRT medication for at least 3 months at the time of baseline visit
  • Subjects rendered menopausal by surgical procedures between the ages of 55 and 65 years

Exclusion Criteria:

  • A history of cancer within 10 years prior to entry into the study, except for relatively "benign" and cured skin cancers such as basal and squamous cell carcinoma
  • A history of hyperparathyroidism, hyperthyroidism, osteomalacia, or other metabolic bone disease within one year prior to enrollment
  • Any condition or disease that may interfere with the evaluation of at least 3 lumbar vertebrae (not necessarily contiguous), determined in a screening radiograph by a radiologist at the central facility (e.g., confluent aortic calcifications, severe osteoarthritis, spinal fusion, lumbar spine fractures)
  • Evidence of clinically significant organic or psychiatric disease on history or physical examination, which in the opinion of the investigator would prevent the patient from completing the study
  • Markedly abnormal pretreatment laboratory finds that, in the opinion of the investigator, would prevent the patient from completing the study
  • A history of using any of the following medications prior to starting study:
  • Any bisphosphonate therapy
  • Selective estrogen receptor modulators (SERMs)
  • Parathyroid hormone
  • Fluorides
  • Calcitonin
  • Calcitriol (>1.5 mcg/week)
  • Corticosteroids on a chronic basis for period equal to or greater then 3 months
  • Received a depot injection of >10,000 IU Vitamin D in the past 12 months
  • A history of recurrent nephrolithiasis or a history of one episode of nephrolithiasis within 1 year of study entry
  • Serum creatinine >1.6 mg/dl
  • Unable to sit or stand upright for 30 minutes after taking the morning dose of risedronate
  • A history of deep vein thrombosis or other coagulation disorders
  • Severe hepatic insufficiency
  • A history of hypersensitivity to raloxifene, risedronate, or to drugs with similar chemical structures
  • Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
  • Subjects found to have one or more vertebral fractures after completing thoracic and LS spine films
  • Subjects who have experienced a low impact fracture related to osteopenia within two years of baseline visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Other: Placebo
Experimental: 1
Risedronate 35mg once a week
Drug: Risedronate
Active Comparator: 2
Raloxifene 60mg daily
Drug: Raloxifene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Compare the effects of risedronate and raloxifene on lumbar spine (LS) bone mineral density (BMD) in osteopenic women previously treated with HRT, who discontinued HRT at least 3 months prior to the study but no greater than 18 mos

Secondary Outcome Measures

Outcome Measure
Compare the effects of risedronate, raloxifene, and placebo on BMD of the hip

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Tara Semanchik, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

November 11, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR4003B_4033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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