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
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