Official Title: “A Non-Inferiority Comparison of 35 mg Delayed-Release Risedronate, Administered Once-Weekly Either Before or After Breakfast, and 5 mg Immediate-Release Risedronate, Administered Once-Daily Before Breakfast, in the Treatment of PMO.”

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Study Type: Interventional

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

Study Primary Completion Date: August 2010

The comparator arms of this risedronate study are 35 mg delayed release given weekly and 5 mg immediate release given daily.

Intervention(s) in this Clinical Trial

• Drug: risedronate
  • 5 mg / Immediate-release (At Least 30 Minutes Before Breakfast) Daily
• Drug: risedronate
  • 35 mg / Delayed-release (Immediately Following Breakfast) Weekly
• Drug: risedronate
  • 35 mg / Delayed-release (At Least 30 Minutes Before Breakfast) Weekly for two years

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 5 mg / Immediate-release for two years
• Experimental: 2
  • 35 mg / Delayed-release for two years
• Experimental: 3
  • 35 mg / Delayed-release (At Least 30 Minutes Before Breakfast)

Primary Measures

• Measure: Percent change from baseline in lumbar spine BMD in 52 weeks in women with post menopausal osteoporosis
  • Time Frame: 52 weeks
    Safety Issue?: Yes

Secondary Measures

• Measure: Change from baseline in BMD of the total proximal femur, femoral neck, and trochanter. Number of patients with at least one new vertebral body fracture. Bone turnover marker changes at Weeks 13, 26, 52 and 104.
  • Time Frame: BMD = Week 26, 52, and 104. New Fx = week 52 and 104
    Safety Issue?: Yes

Inclusion Criteria:

• Female: 50 years of age or older
• >5 years since last menses natural or surgical
• have lumbar spine or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
• BMI >32 kg/m
• use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
• hypocalcemia or hypercalcemia of any cause
• markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

Ana Balske, MD, PhD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00541658

Study ID Number: 2007008

ClinicalTrials.gov Identifier: NCT00541658

Health Authority: United States: Food and Drug Administration