Steroid-Induced Osteoporosis in the Pediatric Population - Canadian Incidence Study (STOPP-CIS)

Children will be recruited into the study following a clinical diagnosis of glucocorticoid-requiring leukemia, rheumatic disease or nephrotic syndrome, as determined by the study collaborators in each of the three sub-specialties according to their usual clinical practice. Potential participants will be identified by the attending physician (oncologist, rheumatologist or nephrologist) who will then refer the patient to the site bone designee. The bone designee (or his/her research assistant) will be responsible for determining patient eligibility and for carrying out the requirements of the study.

Inclusion Criteria:

Inclusion Criteria

1. Children aged > or = 1 month to < or = 16 years at the time of enrolment.

2. Clinical diagnosis of one of the following three diseases:

   1. Acute lymphoblastic leukemia OR
   2. Rheumatic disease,OR
   3. Nephrotic syndrome
3. Need for the first-time initiation of intravenous (IV) or oral glucocorticoid therapy (regardless of the dose or duration) for the treatment of the leukemia, nephrotic syndrome or rheumatic conditions, as determined by the attending physician. IV and oral glucocorticoids used in current clinical practice for the treatment of leukemia, nephrotic syndrome and rheumatic conditions include cortisone, hydrocortisone, methylprednisolone, prednisolone, prednisone, dexamethasone, and deflazacorte. If patients are receiving intra-articular, inhaled, intra-nasal or topical corticosteroids, these agents alone do not meet the steroid criteria for enrolment in the study. However, the use of such steroids will be captured as part of the Case Report Form.
4. Only patients who are receiving glucocorticoids for the first time for the treatment of their underlying leukemia, nephrotic syndrome or rheumatic condition, will be included. Patients who have received glucocorticoids in the past for other indications (e.g. asthma), may be included in the study, provided they have not received more than 14 consecutive days of IV or oral steroids in the 12 months prior to the first initiation of steroids for their underlying leukemia, nephrotic syndrome or rheumatic condition. The pre-STOPP study use of glucocorticoids for 14 days or less, for treatment of unrelated medical conditions in the 12 months prior to the first initiation of steroids to treat the underlying leukemia, nephrotic syndrome or rheumatic conditions, will be captured in the Case Report Form.
5. Informed consent.
6. Ability and willingness to maintain a "Glucocorticoid Dose Diary" throughout the study.
7. For menstruating females, a negative pregnancy test will be required prior to enrolment.

Exclusion Criteria:

1. Inability to obtain baseline investigations within 30 days of the first-time initiation of glucocorticoids for the treatment of the underlying leukemia, nephrotic syndrome or rheumatic condition.
2. Complete immobilization (patient confined to bed except for toileting) for more than 14 consecutive days in the 12 months prior to the initiation of glucocorticoids for the treatment of their underlying leukemia, nephrotic syndrome or rheumatic condition.
3. Use of IV or oral glucocorticoids for more than 14 consecutive days, for the treatment of unrelated medical conditions, in the 12 months prior to the first initiation of steroids for the treatment of the underlying leukemia, nephrotic syndrome or rheumatic condition.
4. Treatment of osteoporosis with medical therapy prior to the initial baseline visit (treatment with, for example, a bisphosphonate, calcitonin, fluoride).
5. Unwillingness to utilize a medically approved method of birth control if menstruating and sexually active.