A Study of Monthly Risedronate for Osteoporosis

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.

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

Conditions

Postmenopausal Osteoporosis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Percent change from baseline in lumbar spine BMD in 12 months in women with post menopausal osteoporosis

Secondary Outcome Measures:

• Change from baseline in BMD of the total proximal femur, femoral neck, and trochanter at months 6, 12, 24
• Number of patients with at least one new vertebral body fracture at months 12 and 24
• Bone turnover marker changes at months 3, 6, 24
• Safety parameters includng clinical labortory values, vital signs and adverse event profiles

Study Start

October 2005; Study completion: August 2008

Eligibility & Criteria

• Ages Eligible for Study: 50 Years and above
• Genders Eligible for Study: Female

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

Total Enrolment

1100

Contact Details

• Heidelberg, Victoria, Australia
• Geelong, Australia
• Saint Leonards, Australia

Contact Proctor and Gamble