1 Year Open-label Extension to CZOL446H2337 Safety and Efficacy Trial of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids for Chronic Inflammatory Conditions

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01197300
First received: September 7, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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 for chronic inflammatory conditions.


Condition Intervention Phase
Osteoporosis
Drug: zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 1-year, Multicenter, Open-label Extension to CZOL446H2337 to Evaluate Safety and Efficacy of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids for Chronic Inflammatory Conditions.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety of zoledronic acid for the treatment of osteoporotic children treated with glucocorticoids for chronic inflammatory conditions by adverse event collection and laboratory results monitoring. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in LS areal BMD Z-score at Month 18 and 24 by core treatment group by dual energy x-ray absorptiometry (DXA). [ Time Frame: Month 18 & 24 ] [ Designated as safety issue: No ]
  • Change from baseline in LS and total body BMC by core treatment group by DXA. [ Time Frame: Month 18 & 24 ] [ Designated as safety issue: No ]
  • Change in biochemical marker values (serum P1NP, BSAP, NTx and TRAP-5b) from baseline. [ Time Frame: Month 18 & 24 ] [ Designated as safety issue: No ]
  • Change in the number of new clinical vertebral fractures and new morphometric vertebral fractures. [ Time Frame: Month 12 & 24 ] [ Designated as safety issue: No ]
  • To evaluate the change from baseline (Visit 1 of the Core study) in pain using the Faces Pain Scale-Revised (FPS-R)by core treatment group. [ Time Frame: Month 15, 18, 21, and 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zoledronic acid
zoledronic acid
Drug: zoledronic acid

  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who met the inclusion criteria for entry into the Core study and who took at least one dose of study drug and have completed the CZOL446H2337 Core study
  • Patients must be enrolled into the extension at visit 9 between 5 and 10 months after Visit 5 of the core study.
  • Patients compliant with the regimen of calcium and vitamin D intake as required in the Core study (at least 800 mg calcium for 6-8 years of age or at least 1300 mg calcium for 9-19 years of age and 400 IU daily vitamin D, through diet or supplementation).
  • Patient who signed the consent form to participate in the study.

Exclusion Criteria:

  • Patients who demonstrated a major protocol violation in the core study
  • Patients for whom the investigator considers participation in the extension study is not appropriate
  • Hypocalcaemia: any value (age-matched) below the normal range at Visit 8
  • Ionized Calcium below the normal range at Visit 9
  • A new malignancy diagnosis during the Core study
  • A new diagnosis of sarcoidosis during the Core study
  • Non-ambulatory patients who require wheelchair assistance for mobility
  • Any prior use of Bisphosphonates other than study drug during the Core study
  • Active hyperparathyroidism or hyper/hypothyroidism during the Core study
  • Any use of anabolic steroids or growth hormone for more than 3 months just prior to entering the extension
  • Use of any other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  • History of hypersensitivity of any of the study drugs or the drugs of similar chemical classes.
  • Women of child-bearing potential unless they use a highly effective method of birth control.

Other protocol-defined exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197300

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Australia, New South Wales
Novartis Investigative Site Recruiting
Westmead, New South Wales, Australia, 2145
Canada, Alberta
Novartis Investigative Site Withdrawn
Calgary, Alberta, Canada, T3B 6A8
Novartis Investigative Site Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Novartis Investigative Site Completed
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
Novartis Investigative Site Completed
Winnipeg, Manitoba, Canada, R3E 0Z2
Canada, Newfoundland and Labrador
Novartis Investigative Site Not yet recruiting
St. John, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Novartis Investigative Site Not yet recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Novartis Investigative Site Withdrawn
Hamilton, Ontario, Canada, L8N 3Z5
Novartis Investigative Site Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
Novartis Investigative Site Not yet recruiting
Montreal, Quebec, Canada, H3H 1P3
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H3T 1C5
Poland
Novartis Investigative Site Withdrawn
Bialystok, Poland, 15-274
Novartis Investigative Site Withdrawn
Warszawa, Poland, 02-637
United Kingdom
Novartis Investigative Site Recruiting
Birmingham, United Kingdom, B4 6NH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01197300     History of Changes
Other Study ID Numbers: CZOL446H2337E1, 2010-020399-41
Study First Received: September 7, 2010
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Canadian Institutes of Health Research
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish Medicines Agency
Poland: Ministry of Health
Romania: Ministry of Public Health
Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Novartis:
Osteoporosis, chronic inflammatory conditions, zoledronic acid, children, glucocorticoids
chronic inflammatory condition

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

ClinicalTrials.gov processed this record on September 15, 2014