Zoledronate for Osteopenia in Pediatric Crohn's

McGill University

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Osteopenia; Crohn's Disease

Treatments: Other: IV saline infusion; Drug: zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00798473

MCH002-56

Details and patient eligibility

About

Background:

• Up to 30% of children and adolescents with Crohn's disease have decreased bone strength, or decrease bone density, called osteopenia.
• Bisphosphonates are a group of drugs that have been well studied and found to be effective in the treatment of osteopenia in menopausal women.
• Zoledronate is a very potent third generation bisphosphonate, that is safe and easy to administer, and has been found effective in the treatment of menopausal women with osteopenia.

Hypothesis: The investigators hypothesize that zoledronate can improve bone density in children and adolescents with Crohn's disease with osteopenia.

Full description

• This study is recruiting 40 children and adolescents, aged 6 to 18, who have a proven abnormal bone density as measured on a special type of x-ray called a DEXA-scan.
• Participants are allocated at random to one of two groups: either treatment with zoledronate, or a placebo.
• Neither the participants or the physicians are aware of which group each participant is in.
• Participants are followed every three months for one year, and assessed with blood tests, urine tests, physical examination, diet questionnaire and exercise questionnaire.
• Participants have a repeat DEXA scan at 6 and 12 months after beginning the study.
• Once all participants are enrolled and followed for one whole year, we will compare the bone density of the group treated with zoledronate with the group treated with placebo.

Enrollment: 13 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged 6 to 18,
• diagnosed with Crohn's disease with osteopenia,
• a minimum of 6 months of adequate calcium and vitamin D intake. (Osteopenia was defined for the purposes of this study as: Z-score lumber spine BMD by DEXA of -2.0 or less, or -1.5 and a risk factor (either steroid use for 6 months or more or decrease of 0.5 z-score in the preceding 12 months).)

Exclusion criteria

• renal dysfunction,
• insufficient calcium or vitamin D intake,
• current medication or condition affecting bone metabolism,
• documented fracture, previously diagnosed bone disease,
• documented intolerance/hypersensitivity to bisphosphonates,
• previous treatment with bisphosphonates within the last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Zoledronic acid, 0.06 mg/kg IV in a single infusion, maximum of 4 mg

Treatment:

Drug: zoledronic acid

2

Placebo Comparator group

Description:

IV saline infusion

Treatment:

Other: IV saline infusion