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Risedronate 75mg Dosed on 2 Consecutive Days Monthly in the Treatment of Osteoporosis in Postmenopausal Women

NCT ID: NCT00358176

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-03-31

Brief Summary

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To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.

To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.

To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

Detailed Description

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Conditions

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Osteoporosis Postmenopausal

Keywords

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Treatment osteoporosis postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Risedronate (HMR4003)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Subjects meeting all of the following criteria were considered for enrollment into the study :

·Ambulatory, healthy postmenopausal women with :

* Natural menopause and more than 5 years after their last menstrual period.
* Or surgical menopause and more than 5 years after surgery (blood hormone tests required for subjects less than 65 years of age who had uterus removed without removal of ovaries at time of surgery).

Osteoporosis (lumbar spine T-score more than 2.5 SD below the mean value in normal young women or more than 2.0 SD below the mean value in normal young women and at least 1 fracture of a vertebra (thoracic-lumbar T4-L4)).

Exclusion Criteria

Subjects with any of the following criteria were not considered for enrollment into the study :

·Women who have received hormone replacement therapy (with estrogen by mouth and/or progestogen and/or androgen) or raloxifene, or other bone active drugs, such as calcitonin, calcitriol/calcidiol/alfacalcidol, parathyroid hormone or any bisphosphonate within 3 months before first dose of study medication.
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis

San Isidro, , Argentina

Site Status

Sanofi-Aventis

Macquarie Park, , Australia

Site Status

Sanofi-Aventis

Laval, , Canada

Site Status

Sanofi-Aventis

Prague, , Czechia

Site Status

Sanofi-Aventis

Paris, , France

Site Status

Sanofi-Aventis

Beirut, , Lebanon

Site Status

Sanofi-Aventis

Warsaw, , Poland

Site Status

Sanofi-Aventis

Midrand, , South Africa

Site Status

Sanofi-Aventis

Istanbul, , Turkey (Türkiye)

Site Status

Sanofi-Aventis

Guildford Surrey, , United Kingdom

Site Status

Countries

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United States Argentina Australia Canada Czechia France Lebanon Poland South Africa Turkey (Türkiye) United Kingdom

Other Identifiers

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HMR4003M/3001

Identifier Type: -

Identifier Source: secondary_id

EFC6063

Identifier Type: -

Identifier Source: org_study_id