CompletedPhase 2/3

Alendronate Osteoporosis Study

20 participantsStarted 2003-03

Plain-language summary

This trial will test the hypothesis that among 20 children and adolescents from Children's Hospital, Boston with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, treatment of glucocorticoid-associated osteopenia and osteoporosis with 18 months of alendronate (FOSAMAX®, Merck \& Co., Inc.) will result in greater improvement in the mean change of individual AP spine bone mineral density (BMD) (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) than treatment with 18 months of standard of care therapy.

Who can participate

Age range

8 Years – 22 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: * Subjects must be diagnosed with either ulcerative colitis, Crohn's disease, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD) or vasculitis according to standard criteria where available, and according to treating physicians when not available. * Subjects must have diminished AP lumbar spine (L1-L4) BMD by DXA (Hologic 4500) with a Z score ≤ -1.5 SD assessed within 8 weeks of the Baseline Visit. * Subjects must have received daily, alternate day or weekly systemic glucocorticoid therapy for a minimum of six months total in their life-time. * Subjects must be between the ages of 8 and 21 years, 11 months, at randomization. Although subjects younger than 8 years of age may be affected by osteoporosis, limited normative data prevents assignment of a BMD Z score for this group. * Regarding subjects with child-bearing potential Females who have had at least one menstrual cycle must either be abstinent or must be using an effective method of birth control. Exclusion Criteria: * Current or recent (within 6 months) treatment with therapeutic doses of a bisphosphonate, calcitonin, human growth hormone, and heparin, all agents known to alter bone density * A history of recent (within one year of screening) major upper gastrointestinal (GI) disease (above the jejunum), including, but not limited to, peptic ulcer, esophageal disease or active GI bleeding, or ever had …

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

To test the hypothesis that among children and adolescents with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, tr

Trial details

NCT IDNCT00277251

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-06

View on ClinicalTrials.gov More Glucocorticoid-Associated Osteopenia and Osteoporosis trials