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

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ClinicalTrials.gov Identifier: NCT00799266
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study is designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids for chronic inflammatory conditions

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Zoledronic acid Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo Controlled Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly Compared to Placebo in Osteoporotic Children Treated With Glucocorticoids for Chronic Inflammatory Conditions
Actual Study Start Date : December 31, 2008
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : March 5, 2018


Arm Intervention/treatment
Experimental: 1
Arm 1
Drug: Zoledronic acid
intravenous infusion

Drug: Zoledronic acid
Placebo Comparator: 2
Arm 2
Drug: Placebo
intravenous infusion

Drug: Placebo



Primary Outcome Measures :
  1. Change in lumbar spine (LS) bone mineral density (BMD) Z-score at Month 12 relative to baseline. [ Time Frame: 1 year ]
  2. Change in lumbar spine (LS) areal bone mineral density (BMD) Z-score at Month 12 relative to baseline. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Between treatment differences for the change in LS BMD Z-score [ Time Frame: at month 6 relative to baseline ]
  2. Between treatment differences for the change in LS and total body BMC. [ Time Frame: at 6 months and 12 months ]
  3. Between treatment differences for the change in serum P1NP, BSAP, NTX, and TRAP-5b. [ Time Frame: at month 6 and month 12 relative to baseline ]
  4. Between treatment differences for the proportion of patients with new vertebral fractures. [ Time Frame: at Month 12 relative to baseline ]
  5. Between treatment differences for change in vertebral morphometry [ Time Frame: at month 12 relative to baseline ]
  6. between treatment differences for change in pain using the Faces Pain Scale- [ Time Frame: at months 3 6, 9 and 12 relative to baseline ]
  7. Between treatment differences for change in 2nd metacarpal cortical width at [ Time Frame: at month 12 relative to baseline ]
  8. Between-treatment differences for the change in LS areal BMD Z-score [ Time Frame: at month 6 relative to baseline ]
  9. Between-treatment differences for the change in LS and total body BMC. [ Time Frame: at 6 months and 12 months ]
  10. Between-treatment differences for the change in serum P1NP, BSAP, NTX, and TRAP-5b. [ Time Frame: at month 6 and month 12 relative to baseline ]
  11. Between-treatment differences for the proportion of patients with new vertebral fractures. [ Time Frame: at Month 12 relative to baseline ]
  12. Between-treatment differences for change in vertebral morphometry [ Time Frame: at month 12 relative to baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of chronic rheumatologic conditions or inflammatory bowel disease requiring systemic glucocorticoids (i.v. or oral)
  • Lumbar Spine areal BMD - Z score of -1.0 or worse
  • Evidence of at least 1 vertebral compression fracture (or radiographic signs of vertebral fracture) within 1 month from Screening visit AND/OR One 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) AND/ OR Two 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)
  • 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
  • Patients who have received testosterone or estrogen therapy may only be included in the trial if these therapies were given as part of physiological replacement in the setting of documented hormonal deficiencies
  • Any medical condition that might interfere with the evaluation of LS BMD, such as severe scoliosis or spinal fusion
  • Low serum calcium, phosphorus or vitamin D
  • Renal impairment
  • 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)
  • Non-ambulatory patients who require wheelchair for mobility
  • History of Kawasaki's disease or Henoch-Schonlein Purpura

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799266


Locations
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Australia, New South Wales
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1200
Novartis Investigative Site
Laeken, Belgium, 1020
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T3B 6A8
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
Novartis Investigative Site
Winnipeg, Manitoba, Canada, R3E 0Z2
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Novartis Investigative Site
Hamilton, Ontario, Canada, L8N 3Z5
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3H 1P3
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1C5
Finland
Novartis Investigative Site
Helsinki, Finland, FIN-00029
Hungary
Novartis Investigative Site
Budapest, Hungary, 1085
Romania
Novartis Investigative Site
Bucharest, Romania, 011461
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 119991
Novartis Investigative Site
Saint-Petersburg, Russian Federation, 195067
South Africa
Novartis Investigative Site
Soweto, Gauteng, South Africa, 2013
United Kingdom
Novartis Investigative Site
Birmingham, United Kingdom, B4 6NH
Novartis Investigative Site
Manchester, United Kingdom, M14 0JH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00799266     History of Changes
Other Study ID Numbers: CZOL446H2337
2008-001252-52 ( EudraCT Number )
First Posted: November 27, 2008    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Osteoporosis, children and adolescents, zoledronic acid, chronic inflammation, Duchenne muscular dystrophy, glucocorticoids
Osteoporosis
chronic inflammatory conditions
zoledronic acid

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic Acid
Glucocorticoids
Bone Density Conservation Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists