Clinical trial NCT00577720: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopausal Women
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2007-12-20
Enrollment: 181
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population
timeFrame: Baseline and Week 13
Secondary outcomes:
measure: Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population
timeFrame: Baseline and Week 13
measure: Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population
timeFrame: Baseline and Week 13
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Research Facility
state: California
city: Gainsville
country: United States
facility: Research Facility
state: Florida
city: Miami
country: United States
facility: Research Facility
state: Florida
city: Honolulu
country: United States
facility: Research Facility
state: Hawaii
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
Study officials:
affiliation: Procter and Gamble
name: Lu A Sun, MD, PhD
role: STUDY_DIRECTOR
References: