CompletedPhase 3

Vertebroplasty for the Treatment of Fractures Due to Osteoporosis

United States131 participantsStarted 2003-04

Plain-language summary

Vertebroplasty is a procedure used to stabilize broken vertebrae, the bones that form the spine. This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis.

Who can participate

Age range

50 Years

Sex

ALL

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: * Confirmed osteoporosis or osteopenia by a referring physician and/or medical history and physical exam OR osteopenia on plain film * Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old * Pain not responsive to standard medical therapy * Current rating for pain intensity of at least 3 on a scale of 0 to 10 Exclusion Criteria: * Evidence or suspicion of malignant tumor or spinal canal compromise * Concomitant hip fracture * Local or systemic infection * Uncorrectable bleeding diatheses * Surgery within the previous 60 days * Lack of access to telephone * Inability to communicate in English * Dementia * Pregnancy * Abnormal renal function or anticipated venography * Conscious sedation is contraindicated for subject

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

Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month

Timeframe: 1 month after procedure

Patient's Rating of Average Pain at 1 Month

Timeframe: 1 month

Trial details

NCT IDNCT00068822

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2012-08-07

View on ClinicalTrials.gov More Spinal Fractures trials

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

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