A one-year multi-center study, to evaluate safety and efficacy of zoledronic acid given every six months compared to placebo in children with weakened bone treated with long-term steroids

Phase 1

• Conditions: Treatment of osteoporosis in a paediatric population (aged 5 to 17 years old) treated with systemic glucocorticoids (i.v. or oral); MedDRA version: 19.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2008-001252-52-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-16
• Last Update Posted: 3 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

? Written informed consent must be obtained before any assessment is
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performed. An assent needs to be provided in accordance with ICH and
local regulations.
? Children, male or female, between 5 and 17 years of age
? 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) requiring treatment with systemic glucocorticoids
(i.v. or oral) within 12 months prior to screening
? Lumbar Spine BMD Z-score of -0.5 or 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 years preceding enrollment in the study,
confirmed by 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 radiological report
*Low trauma fracture is defined as falling from standing height or less.
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 92
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

Exclusion Criteria

Patients/subjects fulfilling any of the following criteria are not eligible
for inclusion in this study. No additional exclusions may be applied by
the investigator, in order to ensure that the study population will be
representative of all eligible patients.
? History of primary bone disease (osteogenesis imperfecta, idiopathic
juvenile osteoporosis, rickets/osteomalacia).
? Any prior use bisphosphonates, or high dose sodium fluoride (i.e.
dental use is permitted)
? Any medical condition that might interfere with the evaluation of LSBMD,
such as severe scoliosis or spinal fusion
? As per Investigator's judgment, patient is anticipated to have surgery
within subsequent year.
? Hypocalcemia and hypophosphatemia: any value (age-matched) below
the normal range at screening
? Serum 25-hydroxy vitamin D concentrations of < 20 ng/mL or < 50
nmol/L at screening
? Renal impairment defined as an estimated glomerular filtration rate
(GFR) < 60ml/min/1.73 m2 at screening based on the Schwartz formula
at screening.
? A serum creatinine increase between Visit 1 and Visit 2 greater than 0.5
mg/dL (44.2mmol/L)
? Uncontrolled symptoms of cardiac failure or arrhythmia.
? 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 active uveitis (symptomatic or asymptomatic) at the time
of enrollment in the study
? History of hypersensitivity to any of the study drugs or its excipients orto drugs of similar chemical classes
? 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
(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 (EOS) Visit.
? [For sites and/or regions where additional safeguards are required
e.g. UK, Italy, Germany, Sweden & etc.: 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. At least one and preferably two complementary forms of
contraception including a barrier method should be used and be
continued throughout the trial and for at least 1 year after completing
the trial. They must also consent to a
pregnancy test prior to every dose administration and at the EOS Visit.
An additional supervised urine pregnancy test will be assessed at Week
12
? History of malignancy of any organ system (other than localized basal
cell carcinoma of the skin or in-situ cervical cancer), treated or
untreated, within the past 5 years, regardless of whether there is
evidence of local recurrence or metastases.
Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified