The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.
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 bisphosphonate treatment, a certain proportion of high-risk patients using chronic GCs either do not achieve a satisfactory gain in bone mineral density (BMD) or develop new fragility fractures. Thus, more potent osteoporosis treatment is necessary for this subgroup of patients. This prompts the current study which aims to examine the efficacy of denosumab in current users of oral bisphosphonates for Glucocorticoid-induced Osteoporosis (GIOP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
60mg subcutaneous injection 6 monthly for 2 doses
continue present bisphosphonate treatment
Tuen Mun Hospital
Hong Kong, China
bone mineral density (BMD) changes at the lumbar spine
Time frame: baseline, 6 months and 12 months
BMD changes in the total hip and femoral neck
Time frame: baseline, 6 months and 12 months
bone turnover markers
Time frame: baseline, 6 months and 12 months
New vertebral fractures
Time frame: 12 months
adverse events
Time frame: 12 months
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