NCT01465568

Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Tuen Mun Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Denosumab	60mg subcutaneous injection 6 monthly for 2 doses
DRUG	bisphosphonates	continue present bisphosphonate treatment

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2011-11-07
• Last updated: 2015-05-12

Locations

1 site across 1 country: China