Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate - Full Text View

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00577720

Purpose

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.

Condition	Intervention	Phase
Postmenopausal Women	Drug: risedronate	Phase II

Drug Information available for: Risedronate sodium Risedronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Efficacy, based on the bone turnover marker of a delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of an immediate-release tablet, administered according to labeling instructions in postmenopausal women. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	168
Study Start Date:	July 2006
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks	Drug: risedronate 35mg immediate release risedronate tablet, once a week for 13 weeks
2: Experimental 35 mg delayed release risedronate tablet, immediatley following breakfast, once a week for 13 weeks	Drug: risedronate 35mg delayed release risedronate tablet, once a week for 13 weeks
3: Experimental 50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks	Drug: risedronate 50mg delayed release risedronate tablet, once a week for 13 weeks
4: Experimental 50 mg delayed release risedronate tablet, immediatley following breakfast, once a week for 13 weeks	Drug: risedronate 35mg delayed release risedronate tablet, once a week for 13 weeks

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.

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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:

25. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577720

Locations

United States, California
Research Facility
Costa Mesa, California, United States
United States, Florida
Research Facility
Miami, Florida, United States
Research Facility
Gainsville, Florida, United States
United States, Hawaii
Research Facility
Honolulu, Hawaii, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Facility
San Antonio, Texas, United States

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Lu A Sun, MD, PhD

Procter and Gamble

More Information

Responsible Party:	Procter and Gamble ( Lu Amy Sun, MD, PhD )
Study ID Numbers:	2005107
Study First Received:	December 19, 2007
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00577720
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Risedronic acid

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009