Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01197300
Other study ID # CZOL446H2337E1
Secondary ID 2010-020399-41
Status Recruiting
Phase Phase 3
First received September 7, 2010
Last updated October 13, 2017
Start date October 25, 2010
Est. completion date April 15, 2019

Study information

Verified date October 2017
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 15, 2019
Est. primary completion date April 15, 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years to 19 Years
Eligibility Key Inclusion criteria:

Written informed consent before any study-related procedure.

Group 1:

1. Children and adolescents, male or female, 6-19 years old, who met the inclusion criteria for entry into the Core study and who took at least one dose of study drug and have completed Visit 8 of the CZOL446H2337 Core study.

2. Patient must be enrolled into the extension at Visit 9 up to 10 months after Visit 5 (month 6) of the Core study.

3. Patients who followed the regimen of calcium and vitamin D intake as required in the Core study through diet or supplementation.

Group 2:

1. Children and adolescents, male or female, 5 - 17 years old who met the inclusion criteria for entry into the Core study but were not enrolled because of clinically significant back pain from vertebral fracture and the preexisting clinical care at the Investigator site is to treat this type of patient with a bisphosphonate.

2. Confirmed diagnosis of non-malignant conditions (including but not limited to rheumatic conditions, inflammatory bowel disease, Duchenne muscular dystrophy, nephrotic syndrome), treated with systemic glucocorticoids (i.v. or oral) within the 12 months preceding enrollment in the study (any duration)

3. LS-BMD Z-score of -0.5 or worse confirmed by the central imaging vendor

4. 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 OR At least one lower OR 2 upper extremity long-bone, low-trauma, fracture which occurred sometime within the 2 years or preceding enrollment in the study, confirmed by radiological report. (*Low trauma fracture is defined as falling from standing height or less).

Key Exclusion criteria:

1. Major protocol violation in the Core Study (Group 1 only).

2. Prior use of bisphosphonates (Group 2 only) or sodium fluoride (doses for osteoporosis not for dental hygiene).

3. Hypocalcemia and hypophosphatemia: any value (age-matched) below the normal range at Visit 8 or 8A.

4. Vitamin D deficiency (serum 25-hydroxy vitamin D concentrations of < 20 ng/mL or < 50 nmol/L) at Visit 8 (Group 1) or Visit 8A (Group 2).

5. Renal impairment defined as an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 at screening based on the Schwartz formula at Visit 8 or 8 A; a serum creatinine above the normal range at Visit 9 (Group 1) or an increase between Visit 8A and Visit 9 greater than 0.5 mg/dL (44.2 ┬Ámol/L) for Group 2.

6. 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 and consent to pregnancy tests during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
zoledronic acid


Locations

Country Name City State
Australia Novartis Investigative Site Westmead New South Wales
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Vancouver British Columbia
South Africa Novartis Investigative Site Soweto Gauteng
Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Pendik
United Kingdom Novartis Investigative Site Manchester
United Kingdom Novartis Investigative Site Sutton Surrey
United Kingdom Novartis Investigative Site West Midlands Birmingham

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Canada,  South Africa,  Turkey,  United Kingdom, 

References & Publications (5)

Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. — View Citation

Glorieux FH, Bishop NJ, Plotkin H, Chabot G, Lanoue G, Travers R. Cyclic administration of pamidronate in children with severe osteogenesis imperfecta. N Engl J Med. 1998 Oct 1;339(14):947-52. — View Citation

Plotkin LI, Weinstein RS, Parfitt AM, Roberson PK, Manolagas SC, Bellido T. Prevention of osteocyte and osteoblast apoptosis by bisphosphonates and calcitonin. J Clin Invest. 1999 Nov;104(10):1363-74. — View Citation

Reid IR, Brown JP, Burckhardt P, Horowitz Z, Richardson P, Trechsel U, Widmer A, Devogelaer JP, Kaufman JM, Jaeger P, Body JJ, Brandi ML, Broell J, Di Micco R, Genazzani AR, Felsenberg D, Happ J, Hooper MJ, Ittner J, Leb G, Mallmin H, Murray T, Ortolani S, Rubinacci A, Saaf M, Samsioe G, Verbruggen L, Meunier PJ. Intravenous zoledronic acid in postmenopausal women with low bone mineral density. N Engl J Med. 2002 Feb 28;346(9):653-61. — View Citation

Ward L, Tricco AC, Phuong P, Cranney A, Barrowman N, Gaboury I, Rauch F, Tugwell P, Moher D. Bisphosphonate therapy for children and adolescents with secondary osteoporosis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005324. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change from (Extension) baseline 2 (Visit 8A) in LS-BMD Z-score at Month 6 and 12. Month 6 and 12
Other Change from (Extension) baseline 2 (Visit 8A) in LS and total body BMC at Month 6 and 12. Month 6 and 12
Other Relative change from (Extension) Baseline 2 in serum N-terminal propeptide type I collagen (P1NP), cross linked N-telopeptide (NTX), bone specific alkaline phosphatase (BSAP) and tartrate-resistant acid phosphatase isoform 5b (TRAP-5b) at Month 6 and 12. Month 6 and 12
Other Proportion of patients with new clinical vertebral fractures during the 12 month period. Month 12
Other Proportion of patients with new morphometric vertebral fracture during the 12 month period. Month 12
Other Change from (Extension) baseline 2 in pain using the Faces Pain Scale-Revised (FPS-R) at Month 3, 6, 9 and 12. Month 3, 6, 9 and 12
Other Change from (Extension) baseline 2 in bone age and 2nd metacarpal cortical width at Month 12. Month 12
Other To demonstrate that zoledronic acid is safe for the treatment of osteoporotic children (with symptomatic vertebral fracture) treated with glucocorticoids, through the monitoring of relevant clinical and laboratory safety parameters. Until 30 days after the patient has stopped study participation
Primary Safety of zoledronic acid for the treatment of osteoporotic children treated with glucocorticoids. To demonstrate that zoledronic acid given long-term, over an additional 12 months from the Core study (CZOL446H2337), is safe for the treatment of osteoporotic children treated with glucocorticoids (Group 1 only) 12 months
Secondary Change from baseline (Visit 1 of the Core study) in LS BMD Z-score at Month 18 and 24 by core treatment group Month 18 & 24
Secondary Change from baseline 1 (Visit 1 of the Core study) in LS and total body BMC at Month 18 and 24 by core treatment group. Month 18 & 24
Secondary Change from baseline 1 in serum N-terminal propeptide type I collagen (P1NP), cross linked N-telopeptide (NTX), bone specific alkaline phosphatase (BSAP) and tartrate-resistant acid phosphatase isoform 5b (TRAP-5b) by core treatment group. Month 18 & 24
Secondary Proportion of patients with new clinical vertebral fractures during the 12 month extension period by core treatment group. Month 12
Secondary Proportion of patients with new morphometric vertebral fracture during the 12 month extension period by core treatment group. Month 12
Secondary Change from baseline 1 (Visit 1 of the Core study) in pain using the Faces Pain Scale-Revised (FPS-R) at Month 15, 18, 21 and 24 by core treatment group. Month 15, 18, 21 and 24
Secondary Change from baseline 1 (Visit 1 of the Core study) in 2nd metacarpal cortical width at month 24 by core treatment group. Month 24
Secondary Change from baseline 1(Visit 1 of the Core study) in bone age and 2nd metacarpal cortical width at month 24 by core treatment group. Month 24
See also
  Status Clinical Trial Phase
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Recruiting NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study N/A
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients N/A
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study N/A
Recruiting NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis Phase 2
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Not yet recruiting NCT01854086 - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday N/A
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
Active, not recruiting NCT01401556 - C-STOP Fracture Trial Phase 3
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Completed NCT02143674 - Muscle Strengthening Exercises and Global Stretching in Elderly N/A
Completed NCT01694784 - Understanding and Discouraging Overuse of Potentially Harmful Screening Tests N/A
Recruiting NCT01549028 - Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT01387672 - Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study Phase 3
Completed NCT01439139 - Bone UltraSonic Scanner (BUSS): Validation Study N/A
Completed NCT01504230 - Multi-joint Coordination Underlies Upright Balance Control in Elderly With Osteoporosis N/A