A multicenter, randomized, double-blind, placebo controlled efficacy and safety trial of intravenous (i.v.) zoledronic acid, twice yearly compared to placebo in osteoporotic children treated with glucocorticoids for chronic inflammatory conditions.
- Conditions
- Treatment of osteoporosis in a paediatric (aged 5 to 17 years old) population treated with glucocorticoids (i.v. or oral) for chronic inflammatory conditions (including rheumatic conditions or inflammatoy bowel disease)MedDRA version: 9.1Level: LLTClassification code 10031282Term: Osteoporosis
- Registration Number
- EUCTR2008-001252-52-FI
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
- Children, male or female, between 5 and 17 years of age at visit 1 of the study
- Confirmed diagnosis of a chronic inflammatory condition, including rheumatic conditions or inflammatory bowel disease (IBD)
- Treatment with systemic glucorticoids (i.v. or oral) within the 12 months preceding enrollment in the sudy (any duration)
- Lumbar Spine areal BMD Z-score of -1.0 or worse and 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
- Ability to obtain informed consent/assent
Amendment:
- Evidence of at least 1 vertebral compression fracture of Genant Grade 1 or higher or
radiographic signs of vertebral fracture)within 1 month from Screening visit, confirmed by central reading. Radiographic signs of fracture
include loss of endplate parallelism, vertebral buckling and endplate interruption.
AND/OR
1 or more, low-trauma, lower extremity long-bone fracture which occurred sometime
within the 2 years PRECEDING, OR following the diagnosis of the underlying
disease (rheumatologic condition/IBD), confirmed by central reading.
AND/ OR
2 or more, low-trauma, upper extremity long-bone fractures which occurred
sometime within the 2 years PRECEDING, OR following the diagnosis of the
underlying disease (rheumatologic condition/IBD), confirmed by central reading.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Any prior use of osteoporosis or bone-modifying therapy, such as bisphosphonates, sodium flouride, calcitonin, calcitriol, SERMs (Selective Estrogen-Receptor Modulators), LHRH agonists, Growth Hormone (GH) or medroxyprogesterone
- Patients who have received testosterone or estrogen therapy may only be included in the trial if these therpies were given as part of physiological replacement in the setting of documented hormonal deficiencies
- Any prior history of malignancy
- Any medical condition that might interfere with the evaluation of LS BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable vertebrae by DXA evaluation on the region of interest (ROI) L1-L4, as confirmed by the central imaging laboratory, will not be considered eligiblefor this study
- Hypocalcemia and hypophosphatemia: any value (age-matched) below the normal range at screening
- Vitamin D deficiency (serum 25-hydroxy vitamin D concentrations of <16 ng/ml or <40 nmol/L) at screening
- Renal impairment defined as an estimated glomerular filtration rate (GFR)<35 ml/min/1.73 m2 at screening based on the Schwartz formula
- A serum creatinine increase between Visit 1 and Visit 2 greater than 0.5 mg/dL (44.2 µmol/L)
- History of hyperparathyroidism or hyperthyroidism within 1 year of screening
- 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 cative uveitis (symptomatic or asymptomatic) at the time of enrollment of the study
- 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 screenng visit. Females of childbearing 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
- History of primary bone disease (osteogenesis imperfecta, iodopathic juvenile osteoporosis, rickets/osteomalacia)
- Non-ambulatory patients who require wheelchair assistance for mobility
- History of Kawasaki's disease or Henoch-Schonlein Purpura
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method