TerminatedPhase 4

Bone Microarchitecture in Osteopenic Postmenopausal Women

United States, Argentina13 participantsStarted 2008-07

Plain-language 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.

Who can participate

Age range40 Years – 57 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius

Timeframe: 12 months

Trial details

NCT IDNCT00577395

SponsorWarner Chilcott

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-02

Results submitted2009-11-18

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