1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic acid
Intervention description: intravenous infusion
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 5 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Osteoporosis, children and adolescents, zoledronic acid, chronic inflammation, Duchenne muscular dystrophy, glucocorticoids, chronic inflammatory conditions

Summary:

      This 1-year open-label extension to CZOL446H2337 is designed to evaluate the safety and
      efficacy of zoledronic acid twice yearly in osteoporotic children treated with
      glucocorticoids.
    

Eligibility criteria:

        Key Inclusion criteria:

        Written informed consent before any study-related procedure.

        Group 1:

          1. Children and adolescents, male or female, 6-19 years old, who met the inclusion
             criteria for entry into the Core study and who took at least one dose of study drug
             and have completed Visit 8 of the CZOL446H2337 Core study.

          2. Patient must be enrolled into the extension at Visit 9 up to 10 months after Visit 5
             (month 6) of the Core study.

          3. Patients who followed the regimen of calcium and vitamin D intake as required in the
             Core study through diet or supplementation.

        Group 2:

          1. Children and adolescents, male or female, 5 - 17 years old who met the inclusion
             criteria for entry into the Core study but were not enrolled because of clinically
             significant back pain from vertebral fracture and the preexisting clinical care at the
             Investigator site is to treat this type of patient with a bisphosphonate.

          2. Confirmed diagnosis of non-malignant conditions (including but not limited to
             rheumatic conditions, inflammatory bowel disease, Duchenne muscular dystrophy,
             nephrotic syndrome), treated with systemic glucocorticoids (i.v. or oral) within the
             12 months preceding enrollment in the study (any duration)

          3. LS-BMD Z-score of -0.5 or worse confirmed by the central imaging vendor

          4. Evidence of at least 1 vertebral compression fracture (at least Genant Grade 1
             vertebral compression or radiographic signs of vertebral compression) confirmed by
             central reading OR At least one lower OR 2 upper extremity long-bone, low-trauma,
             fracture which occurred sometime within the 2 years or preceding enrollment in the
             study, confirmed by radiological report. (*Low trauma fracture is defined as falling
             from standing height or less).

        Key Exclusion criteria:

          1. Major protocol violation in the Core Study (Group 1 only).

          2. Prior use of bisphosphonates (Group 2 only) or sodium fluoride (doses for osteoporosis
             not for dental hygiene).

          3. Hypocalcemia and hypophosphatemia: any value (age-matched) below the normal range at
             Visit 8 or 8A.

          4. Vitamin D deficiency (serum 25-hydroxy vitamin D concentrations of < 20 ng/mL or < 50
             nmol/L) at Visit 8 (Group 1) or Visit 8A (Group 2).

          5. Renal impairment defined as an estimated glomerular filtration rate (GFR) < 60
             mL/min/1.73 m2 at screening based on the Schwartz formula at Visit 8 or 8 A; a serum
             creatinine above the normal range at Visit 9 (Group 1) or an increase between Visit 8A
             and Visit 9 greater than 0.5 mg/dL (44.2 μmol/L) for Group 2.

          6. Female patients of child bearing potential are eligible only if they are not
             pregnant/non-lactating. Females of child bearing potential must be practicing a
             medically acceptable form of birth control for greater than 2 months prior to
             screening visit and consent to pregnancy tests during the study.