Denosumab Versus Bisphosphonates (Alendronate) in GIOP

Denosumab Versus Oral Bisphosphonate (Alendronate) for Osteoporosis in Long-term Glucocorticoid Users: an Open Randomized Controlled Trial

A randomized controlled trial to compare for the efficacy and tolerability of denosumab and oral alendronate in the management of glucocorticoid induced osteoporosis

Study design: an open-label randomized controlled trial Duration of study: 12 months

Treatment arms:

1. Denosumab: a total of 2 doses in a period of 12 months
2. Oral alendronate: weekly dose in a period of 12 months Target sample size: 220 patients (110 patients in each arm)

Inclusion Criteria:

1. Adults (women or men) >18 years of age
2. Receiving long-term prednisolone treatment for various medical illnesses, defined as a daily prednisolone dose of ≥2.5mg/day for ≥12 months).
3. Informed consent from patients.
4. Willing to comply with all study procedures

Exclusion Criteria:

1. Patients with previous use of denosumab, teriparatide, intravenous bisphosphonates, strontium or other experimental anti-osteoporotic agents.
2. Premenopausal women who plan for pregnancy within 18 months of study entry.
3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
4. Patients with unexplained hypocalcemia.
5. Patients with serum creatinine level of >=200umol/L.