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

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

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal
• Intervention / Treatment: Drug: risedronate; Drug: risedronate; Drug: risedronate; Drug: experimental

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada
      • Research Facility
    • Sainte-Foy, Quebec, Canada
      • Research Facility
• Croatia
  • Zagreb, Croatia
    • Research Facility
• Netherlands
  • Amsterdam, Netherlands
    • Research Facility
  • Leiden, Netherlands
    • Research Facility
• Poland
  • Bialystok, Poland
    • Research Facility
  • Lublin, Poland
    • Research Site
  • Warszawa, Poland
    • Research Site
  • Wroclaw, Poland
    • Research Site
• United States
  • Florida
    • Daytona Beach, Florida, United States
      • Research Site
    • Gainesville, Florida, United States
      • Research Site
  • Kansas
    • Shawnee Mission, Kansas, United States
      • Research Site
  • Texas
    • San Antonio, Texas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 5 mg risedronate, once daily for 6 months	Drug: risedronate; tablet, 5 mg risedronate daily for 6 months; Drug: risedronate; tablet, 100 mg risedronate monthly for 6 months; Drug: risedronate; tablet, 150 mg risedronate monthly for 6 months
Experimental: 2; 100 mg risedronate, once a month for 6 months	Drug: risedronate; tablet, 5 mg risedronate daily for 6 months; Drug: risedronate; tablet, 100 mg risedronate monthly for 6 months; Drug: risedronate; tablet, 150 mg risedronate monthly for 6 months
Experimental: 3; 150 mg risedronate, once a month for 6 months	Drug: risedronate; tablet, 5 mg risedronate daily for 6 months; Drug: risedronate; tablet, 100 mg risedronate monthly 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Collaborators: Sanofi
• Investigators: Study Director: John Beary, MD, Procter and Gamble

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 20, 2007

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid; Etidronic Acid
• Other Study ID Numbers: 2003134; HMR4003K/2001