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Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

NCT ID: NCT00577837

Last Updated: 2013-04-17

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

PHASE2

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-06-30

Brief Summary

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A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

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Detailed Description

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Conditions

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Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

5 mg risedronate, once daily for 6 months

Group Type ACTIVE_COMPARATOR

risedronate

Intervention Type DRUG

tablet, 5 mg risedronate daily for 6 months

2

100 mg risedronate, once a month for 6 months

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

tablet, 100 mg risedronate monthly for 6 months

3

150 mg risedronate, once a month for 6 months

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

tablet, 150 mg risedronate monthly for 6 months

4

200 mg risedronate, once a month for 6 months

Group Type EXPERIMENTAL

experimental

Intervention Type DRUG

tablet, 200 mg risedronate monthly for 6 months

Interventions

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risedronate

tablet, 5 mg risedronate daily for 6 months

Intervention Type DRUG

risedronate

tablet, 100 mg risedronate monthly for 6 months

Intervention Type DRUG

risedronate

tablet, 150 mg risedronate monthly for 6 months

Intervention Type DRUG

experimental

tablet, 200 mg risedronate monthly for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal

Exclusion Criteria

* use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:

* oral or parenteral glucocorticoids (5 mg prednisone or equivalent per day)
* anabolic steroids
* estrogen, raloxifene or estrogen-related drugs, eg, tamoxifen, tibolone, (except for low dose vaginal creams, tablets or insertable estrogen ring
* progestogen
* calcitonin
* vitamin D supplements (greater than 800 IU per day)
* calcitriol, calcidiol, or alfacalcidol
* any bisphosphonate
* fluoride (10 mg per day)
* strontium and other bone active agents
* parathyroid hormone
* heparin, warfarin, and other similar anticoagulants
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Warner Chilcott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Beary, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Research Site

Daytona Beach, Florida, United States

Site Status

Research Site

Gainesville, Florida, United States

Site Status

Research Site

Shawnee Mission, Kansas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Research Site

Hamilton, Ontario, Canada

Site Status

Research Facility

Montreal, Quebec, Canada

Site Status

Research Facility

Sainte-Foy, Quebec, Canada

Site Status

Research Facility

Zagreb, , Croatia

Site Status

Research Facility

Amsterdam, , Netherlands

Site Status

Research Facility

Leiden, , Netherlands

Site Status

Research Facility

Bialystok, , Poland

Site Status

Research Site

Lublin, , Poland

Site Status

Research Site

Warsaw, , Poland

Site Status

Research Site

Wroclaw, , Poland

Site Status

Countries

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United States Canada Croatia Netherlands Poland

Other Identifiers

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HMR4003K/2001

Identifier Type: -

Identifier Source: secondary_id

2003134

Identifier Type: -

Identifier Source: org_study_id

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