Steroid-Induced Osteoporosis in the Pediatric Population - Canadian Incidence Study (STOPP-CIS)
|ClinicalTrials.gov Identifier: NCT01663129|
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : September 27, 2017
To determine the magnitude and rate of bone mass deficits following initiation of glucocorticoid therapy for the treatment of pediatric leukemia, rheumatic conditions and nephrotic syndrome, we propose a 6 year, prospective study in 12 academic, tertiary care centres across Canada.
The investigators hypothesize that glucocorticoid-treated children with leukemia, rheumatic conditions and nephrotic syndrome will fail to accrue bone mass at a normal rate, and that deficits in mineral accrual will occur in a glucocorticoid dose- and duration-dependent fashion. We also hypothesize that the fracture incidence will increase with concomitant reductions in bone mass.
|Condition or disease|
|Acute Lymphoblastic Leukemia Nephrotic Syndrome Rheumatism|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||406 participants|
|Official Title:||Steroid-Induced Osteoporosis in the Pediatric Population - Canadian Incidence Study (STOPP-CIS)|
|Study Start Date :||January 2005|
|Primary Completion Date :||March 6, 2014|
|Study Completion Date :||March 6, 2014|
Leukemia Patient Group
Acute Lymphoblastic Leukemia (ALL)
Rheumatic Disease Patient Group
Nephrotic Syndrome Patient Group
Nephrotic syndrome will be classified according to the following categories:
Idiopathic nephrotic syndrome, without renal biopsy histology, presumed minimal change disease (MCD), Focal segmental glomerulosclerosis (FSGS), confirmed on biopsy, Minimal change disease, confirmed on biopsy Nephrotic syndrome with Henoch-Schonlein Purpura (HSP).
- The magnitude and rate of total body, hip and lumbar spine bone mass deficits [ Time Frame: up to 72 months (plus at 3 months post baseline visit for the Nephrotic Syndrome Group) ]We will determine the magnitude and rate of total body, hip and lumbar spine bone mass deficits following initiation of glucocorticoid therapy, in relation to glucocorticoid dose and duration, among children with leukemia, rheumatic conditions and nephrotic syndrome. The longitudinal pattern of deficits (or gains) in bone mass will be determined for each disease state by plotting bone mass measurements taken at 6 month intervals throughout the study, with an additional 3 month measurement being recorded for patients with nephrotic syndrome.
- Glucocorticoid threshold dose [ Time Frame: At baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66 and 72-month visits ]To identify whether a glucocorticoid threshold dose exists for each of the three disease categories, above which significant deficits in bone mass are likely to occur.
- Frequency of atraumatic fractures [ Time Frame: At baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66 and 72-month visits ]To assess the frequency of atraumatic fractures in relation to glucocorticoid dose and duration for each of the three chronic illnesses.
- Fracture risk [ Time Frame: At baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66 and 72-month visits ]To determine the fracture risk associated with a given reduction in bone mass from baseline, for each of the three chronic diseases.
- Magnitude of bone mass restitution [ Time Frame: At baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66 and 72-month visits ]To determine the magnitude of bone mass restitution when glucocorticoid therapy is withdrawn, and to evaluate whether recovery is age- and/or pubertal stage-dependent.
- Handedness and lateralization of bone density [ Time Frame: Once during either the baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66 or 72-month visits ]To investigate the relationship between handedness and lateralization of bone density.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663129
|Alberta Children's Hospital|
|Calgary, Alberta, Canada, T3B 6A8|
|Stollery Children's Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|
|Canada, British Columbia|
|BC Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Winnipeg Children's Hospital|
|Winnipeg, Manitoba, Canada, R3E 3P4|
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8N 3Z5|
|London Health Sciences Centre|
|London, Ontario, Canada, N6C 2V5|
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Shriners Hospital for Children|
|Montreal, Quebec, Canada, H3G 1A6|
|Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3H 1P3|
|Hopital Sainte Justine|
|Montreal, Quebec, Canada, H3T 1C5|
|Principal Investigator:||Leanne M Ward, MD FRCPC||Children's Hospital of Eastern Ontario|