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

Sponsor:	Warner Chilcott
Collaborator:	Sanofi-Aventis
Information provided by:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00577837

Purpose

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	Intervention	Phase
Postmenopausal	Drug: risedronate Drug: experimental	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	370
Study Start Date:	April 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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-Aventis

Investigators

Study Director:

John Beary, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Dietrich H Wenderoth, MD, Proctor and Gamble
ClinicalTrials.gov Identifier:	NCT00577837 History of Changes
Other Study ID Numbers:	2003134, HMR4003K/2001
Study First Received:	December 19, 2007
Last Updated:	March 22, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Risedronic acid
Etidronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012