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

Information source: Procter and Gamble
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postmenopausal

Intervention: risedronate (Drug); risedronate (Drug); risedronate (Drug); experimental (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Procter and Gamble

Official(s) and/or principal investigator(s):
John Beary, MD, Study Director, Affiliation: Procter and Gamble

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.

Clinical Details

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome: 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

Eligibility

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Female.

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

Locations and Contacts

Research Facility, Zagreb, Croatia

Research Facility, Leiden, Netherlands

Research Facility, Amsterdam, Netherlands

Research Facility, Bialystok, Poland

Research Site, Warszawa, Poland

Research Site, Lublin, Poland

Research Site, Wroclaw, Poland

Research Site, Gainesville, Florida, United States

Research Site, Daytona Beach, Florida, United States

Research Site, Shawnee Mission, Kansas, United States

Research Site, Hamilton, Ontario, Canada

Research Facility, Sainte-Foy, Quebec, Canada

Research Facility, Montreal, Quebec, Canada

Research Site, San Antonio, Texas, United States

Additional Information

Starting date: April 2004
Ending date: June 2005
Last updated: February 5, 2008

Page last updated: June 20, 2008

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