Status:
COMPLETED
Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis
Lead Sponsor:
Tuen Mun Hospital
Conditions:
Osteoporosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
There are no data on the use of denosumab in steroid induced osteoporosis. Postmenopausal women with chronic use of Glucocorticoid (GCs) are at high-risk of osteoporotic fractures. Despite bisphosphon...
Eligibility Criteria
Inclusion
- 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.
- A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.
- Having received oral bisphosphonate treatment for at least 2 years.
- 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.
- Informed consent from patients.
Exclusion
- Patients with previous use of denosumab or teriparatide.
- Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.
- Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
- Patients with unexplained hypocalcemia.
- Patients with serum creatinine level of \>=200umol/L.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01465568
Start Date
December 1 2011
End Date
June 1 2014
Last Update
May 12 2015
Active Locations (1)
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1
Tuen Mun Hospital
Hong Kong, China