CompletedPhase 4

Bisphosphonate Therapy for Osteogenesis Imperfecta

18 participantsStarted 1999-08

Plain-language summary

The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures.

Who can participate

Age range

3 Years – 21 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: * Diagnosis of OI, as defined by genetic analysis revealing a defect of type I collagen, OR by bone mineral density (BMD) \<2.5 standard deviations (SD) for age plus two of the following: * Family history of OI * Frequent fractures * Blue sclerae * Multiple wormian bones on skull x-ray * Hearing disturbance * Dentinogenesis imperfecta * Age between 3 and 21 years at the start of the study period. * Children must be able to swallow whole tablets * Parents of children must be able to understand protocol and give informed consent. Exclusion Criteria: * Therapy with bisphosphonates during the past 12 months. * Other "non-traditional" therapy for OI in the last 6 months, such as growth hormone or anabolic steroids. * Other chronic diseases besides OI that interfere with bone morphology or gastrointestinal absorption

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

Bone Mineral Density

Timeframe: 2 years

Trial details

NCT IDNCT00159419

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-08

Results submitted2013-11-12

View on ClinicalTrials.gov More Osteogenesis Imperfecta trials