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.
Verified January 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01197300
First received: September 7, 2010
Last updated: January 2, 2013
Last verified: January 2013
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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: | 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: | 92 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | July 2019 |
| Estimated Primary Completion Date: | July 2019 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197300
Contacts
| Contact: Novartis Pharmaceuticals | +41-61-324-1111 |
Locations
| Australia, New South Wales | |
| Novartis Investigative Site | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Canada, Alberta | |
| Novartis Investigative Site | Not yet recruiting |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Novartis Investigative Site | Not yet recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Novartis Investigative Site | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Manitoba | |
| Novartis Investigative Site | Not yet recruiting |
| 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 | Not yet recruiting |
| 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 | |
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: | January 2, 2013 |
| 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 May 16, 2013