Bone Microarchitecture in Osteopenic Postmenopausal Women

Phase 4TerminatedNCT00577395

Warner Chilcott13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoporosis

Interventions

placeboDRUG

oral tablet once a month for 12 months

risedronateDRUG

tablet, 150 mg once a month for 12 months

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 57 Years

Medical Language ↔ Plain English

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

Locations (4)

Research Facility

Tuscon, Arizona, United States

Research Facility

Omaha, Nebraska, United States

Research Site

Cincinnati, Ohio, United States

Research Facility

Buenos Aires, Argentina

Outcomes

Primary Outcomes

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

The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF). NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.

Time frame: 12 months

Secondary Outcomes

Erosion Index of the Distal Radius

Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.

Time frame: 6 months

Data from ClinicalTrials.gov

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