Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuen Mun Hospital
• Treatments: Denosumab; Diphosphonates; Glucocorticoids

Criteria

Inclusion Criteria:

1. Women or adult men (>18 years of age) with various medical diseases requiring long-term prednisolone treatment. Pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period.

2. A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.

3. Having received oral bisphosphonate treatment for at least 2 years.

4. Suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip BMD values to increase; (2) values of lumbar spine, femoral neck or total hip BMD remain osteoporotic, ie. T scores < -2.5 or Z scores < -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance.

5. Informed consent from patients.

Exclusion Criteria:

1. Patients with previous use of denosumab or teriparatide.

2. Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.

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.