Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

Phase 2

Completed

• Conditions: Postmenopausal Women
• Interventions: Drug: risedronate

• Registration Number: NCT00577720
• Lead Sponsor: Warner Chilcott

Brief Summary

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Detailed Description

To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Results First Submitted: 2011-08-12
• Status Verified: 2011-11
• Results First Submitted QC: 2011-12-06
• Last Update Submitted: 2011-12-06
• Results First Posted: 2012-01-13
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 181

Inclusion Criteria

• In generally good health, as determined by medical history, physical examination, and laboratory test results
• Postmenopausal greater than 2 years, naturally or surgically based on medical history.

Exclusion Criteria

• Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:

  • oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
  • anabolic steroids
  • estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
  • progestins
  • calcitonin
  • vitamin D supplements
  • calcitriol, calcidiol, or alfacalcidol at any dose
  • any bisphosphonate
  • fluoride
  • strontium
  • parathyroid hormone, including teriparatide

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
35 mg IRBB	risedronate	35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
50 mg DRBB	risedronate	50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
35 mg DRFB	risedronate	35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
50 mg DRFB	risedronate	50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks

Primary Outcome Measures

Name	Time	Method
Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population	Baseline and Week 13

Secondary Outcome Measures

Name	Time	Method
Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population	Baseline and Week 13
Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population	Baseline and Week 13

Trial Locations

Locations (2)

Research Site; 🇺🇸 Dallas, Texas, United States

Research Facility; 🇺🇸 San Antonio, Texas, United States