Bone Microarchitecture in Osteopenic Postmenopausal Women

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00577395

Run by

Warner Chilcott

People needed

13

Starts

2008-07-01

Expected to finish

2009-02-01

Last updated by the study team

2013-04-22

Who can join

Age: 40 and older, up to 57. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Facility — Tuscon, Arizona, United States
• Research Facility — Omaha, Nebraska, United States
• Research Site — Cincinnati, Ohio, United States
• Research Facility — Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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