Bone Microarchitecture in Osteopenic Postmenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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A 12-month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing 150 mg Once-a-month Risedronate and Placebo Using 3-dimensional Micro MRI (Magnetic Resonance Imaging).

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: placebo
* Drug: risedronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>one 150 mg risedronate once a month, orally | Drug: risedronate<br>* tablet, 150 mg once a month for 12 months<br>|
| Placebo Comparator: 1<br>Placebo tablet once a month, orally | Drug: placebo<br>* oral tablet once a month for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erosion Index of the Distal Radius | Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed. | 6 months |