A Phase II Study Evaluating SB-751689 in Post-Menopausal Women With Osteoporosis.

This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.

Official Title

Study CR9108963: A Dose-Range Finding Study of SB-751689 in Post-Menopausal Women With Osteoporosis

Conditions

Osteoporosis

Study Type

Interventional

Study Design

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

Further Details

Primary Outcome Measures:

• Data from this study, along with other data, will be used to select a dose of SB-751689 for further evaluation based on the effect seen on bone mineral density, safety and tolerability, in comparison with placebo and 2 active comparators. [Time Frame: 12 Months]

Secondary Outcome Measures:

• Bone mineral density of the lumbar spine and hip Volumetric bone mineral density and other parameters at the hip and spine Vertebral and hip strength and hip structure parameters Biomarkers of bone turnover PK/PD relationships Safety evaluation [Time Frame: 12 Months]

Study Start

May 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 79 Years
• Genders Eligible for Study: Female

Inclusion Criteria:

• Post-menopausal women of <80 years of age
• At least 5 years post-menopausal

Exclusion Criteria:

• More than one fracture of the spine
• Any osteoporosis related/fragility fracture, not including the spine, since age 40
• Previous treatment with strontium ranelate or intravenous bisphosphonate
• Treatment with oral bisphosphonate within the last 6 months
• Treatment with parathyroid hormone within the last 2 years
• Obesity
• Rheumatoid arthritis, cancer (other than basal skin cancer)in the last 5 years, history of or active liver disease (except Gilbert’s syndrome), history of or active kidney stones
• Current therapy with digoxin, diltiazem or verapamil

Total Enrolment

520

Contact Details

• St Leonards, New South Wales, 2065, Australia
• Geelong, Victoria, 3220, Australia
• Heidelburg, Victoria, 3081, Australia
• Footscray, Victoria, 3011, Australia

GSK Clinical Trials Call Centre 1-877-379-3718