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

Postmenopausal Women Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577720
• Other study ID #: 2005107
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2007
• Last updated: December 6, 2011
• Start date: July 2006
• Est. completion date: January 2007

Study information

• Verified date: November 2011
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

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

Locations

Country	Name	City	State
United States	Research Facility	Costa Mesa	California
United States	Research Site	Dallas	Texas
United States	Research Facility	Gainsville	Florida
United States	Research Facility	Honolulu	Hawaii
United States	Research Facility	Miami	Florida
United States	Research Facility	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population		Baseline and Week 13	No
Secondary	Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population		Baseline and Week 13	No
Secondary	Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population		Baseline and Week 13	No