An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

Inclusion Criteria:

- Children, male or female between 5 and 17 years of age

- A confirmed diagnosis of non-malignant conditions requiring treatment with systemic
glucocorticoids (including but not limited to chronic rheumatologic conditions or
inflammatory bowel disease or Duchenne Muscular Dystrophy) receiving treatment with
systemic glucocorticoids (i.v. or oral) within the preceding 12 months from
screening.

- Lumbar Spine areal BMD - Z score of -0.5or worse confirmed by the central imaging
vendor

- Evidence of at least 1 vertebral compression fracture of Genant Grade 1 or higher or
radiographic signs of vertebral compression fracture) seen in X-ray within 1 month of
or at Screening visit, confirmed by central reading. Radiographic signs of fracture
include loss of endplate parallelism, vertebral buckling and endplate interruption.

OR

One or more, low-trauma, lower extremity long-bone fracture which occurred sometime within
the 2 yearspreceding enrollment in the study, confirmed by central reading or radiological
report

OR

Two or more, low-trauma, upper extremity long-bone fractures which occurred sometime
within the 2 years preceding enrollment in the study, confirmed by central reading or
radiological report.

• Consent/assent to study participation

Exclusion Criteria:

- Any prior use of bisphosphonates, sodium fluoride, calcitonin, SERMs (Selective
Estrogen-Receptor Modulators), LHRH agonists, Growth Hormone (GH) or
medroxyprogesterone. Any medical condition that might interfere with evaluation of LS
BMD such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable
vertebrae by DXA evaluation in the region of interest (ROI) L1-L4, as confirmed by
the central imaging laboratory, will not be considered eligible for this study. For
Duchenne Muscular Dystrophy, as per Investigator's judgment, patient is anticipated
to have surgery within subsequent year.

- Duchenne Muscular Dystrophy patient with history of serious renal disease.

- Duchenne Muscular Dystrophy patient with symptomatic cardiac abnormality.

- Low serum calcium, phosphorus or vitamin D

- Renal impairment

- A serum creatinine increase between Visit 1 and Visit 2 greater than 0.5 mg/dL (44.2
mmol/L).

- History of hyperparathyroidism or hyperthyroidism within 1 year

- History of hypothyroidism unless on a stable treatment regimen for > 6 months, with
at least one documented normal TSH and FT4 levels during this 6 month period

- History of sarcoidosis.

- Diagnosis of active uveitis (symptomatic or asymptomatic)

- Female patients of child bearing potential are eligible only if they are: (1) not
pregnant/ non-lactating; (2) are sexually abstinent or are surgically sterile and (3)
if sexually active, must be practicing a medically acceptable form of birth control
for greater than 2 months prior to screening visit. Females of child bearing
potential who are sexually active must agree to continue to practice their birth
control during the trial and at least 1 year after completing the trial and must
consent to a pregnancy test prior to every dose administration and at the end of
study visit

- History of malignancy

- History of primary bone disease (osteogenesis imperfecta, idiopathic juvenile
osteoporosis, rickets/osteomalacia)

Other protocol-defined inclusion/exclusion criteria may apply.