Bone Microarchitecture in Osteopenic Postmenopausal Women (NCT00577395) | Clinical Trial Compass
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 range
40 Years – 57 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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