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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00577837
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : April 17, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postmenopausal Drug: risedronate Drug: experimental Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Active-controlled, Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density
Study Start Date : April 2004
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
5 mg risedronate, once daily for 6 months
Drug: risedronate
tablet, 5 mg risedronate daily for 6 months
Experimental: 2
100 mg risedronate, once a month for 6 months
Drug: risedronate
tablet, 100 mg risedronate monthly for 6 months
Experimental: 3
150 mg risedronate, once a month for 6 months
Drug: risedronate
tablet, 150 mg risedronate monthly for 6 months
Experimental: 4
200 mg risedronate, once a month for 6 months
Drug: experimental
tablet, 200 mg risedronate monthly for 6 months


Outcome Measures

Primary Outcome Measures :
  1. Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577837


Locations
United States, Florida
Research Site
Daytona Beach, Florida, United States
Research Site
Gainesville, Florida, United States
United States, Kansas
Research Site
Shawnee Mission, Kansas, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Canada, Quebec
Research Facility
Montreal, Quebec, Canada
Research Facility
Sainte-Foy, Quebec, Canada
Croatia
Research Facility
Zagreb, Croatia
Netherlands
Research Facility
Amsterdam, Netherlands
Research Facility
Leiden, Netherlands
Poland
Research Facility
Bialystok, Poland
Research Site
Lublin, Poland
Research Site
Warszawa, Poland
Research Site
Wroclaw, Poland
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: John Beary, MD Procter and Gamble
More Information

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577837     History of Changes
Other Study ID Numbers: 2003134
HMR4003K/2001
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs