Official Title: “A Phase III, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel Group, Non-Inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of PMO”

The purpose of this trial is to study the efficacy of a single-dose monthly 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, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Intervention(s) in this Clinical Trial

• Drug: risedronate
  • tablet, 5 mg risedronate, once a day for 2 years
• Drug: risedronate
  • oral, 150 mg risedronate, once a month for 2 years

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 5 mg risedronate, once daily for 2 years
• Experimental: 2
  • 150 mg risedronate taken once a month for 2 years

Primary Measures

• Percent change from baseline in lumbar spine BMD in 12 months in women with post menopausal osteoporosis
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Change from baseline in BMD of the total proximal femur, femoral neck, and trochanter at months 6, 12, 24
  • Time Frame: 6, 12, 24 months
    Safety Issue?: No
• Number of patients with at least one new vertebral body fracture at months 12 and 24
  • Time Frame: 12 and 24 months
    Safety Issue?: No
• Bone turnover marker changes at months 3, 6, 24
  • Time Frame: 3, 6, and 24 Months
    Safety Issue?: No
• Safety parameters including clinical laboratory values, vital signs and adverse event profiles
  • Time Frame: 12 and 24 months
    Safety Issue?: No

Inclusion Criteria:

• Female: 50 years of age or older
• >5 years since last menses natural or surgical
• have lumbar spine BMD more that 2.5 SD below the yond adult mean, or have 1-spine BMD more than 2.0 SD below the yond 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

Sal Bartelmo, MD Study Director P&G  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00247273

Study ID Number: 2005032

ClinicalTrials.gov Identifier: NCT00247273

Health Authority: United States: Food and Drug Administration