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

Official Title: “Study to Assess the Efficacy, Safety and Pharmacokinetics of Risedronate Upon Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Administered Weekly for 13 Weeks to Postmenopausal Women”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: risedronate
  • 35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks
• Drug: risedronate
  • 35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
• Drug: risedronate
  • 50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks
• Drug: risedronate
  • 50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 35 mg IRBB
  • 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
• Experimental: 35 mg DRFB
  • 35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
• Experimental: 50 mg DRFB
  • 50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
• Experimental: 50 mg DRBB
  • 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Primary Measures

• Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
  • Time Frame: Baseline and Week 13
    Safety Issue?: No

Secondary Measures

• Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population
  • Time Frame: Baseline and Week 13
    Safety Issue?: No
• Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population
  • Time Frame: Baseline and Week 13
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Lu A Sun, MD, PhD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00577720

Study ID Number: 2005107

ClinicalTrials.gov Identifier: NCT00577720

Health Authority: United States: Food and Drug Administration