Bone Microarchitecture in Osteopenic Postmenopausal Women

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-02-28

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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

one 150 mg risedronate once a month, orally

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

tablet, 150 mg once a month for 12 months

1

Placebo tablet once a month, orally

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral tablet once a month for 12 months

Interventions

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placebo

oral tablet once a month for 12 months

Intervention Type DRUG

risedronate

tablet, 150 mg once a month for 12 months

Intervention Type DRUG

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

57 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No