Bone Microarchitecture in Osteopenic Postmenopausal Women

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Collaborator: Sanofi
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria:

• Female: 40 and 57 years of age inclusive

• cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment

• have osteopenia defines as having the following: have osteopenia defined as having the following:

• Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR

• Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;

• have a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria:

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

• 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