Efficacy of minodronate and denosumab for bone loss in patients with prostate cancer undergoing androgen deprivation therapy
Phase 3
- Conditions
- Osteopenia
- Registration Number
- JPRN-UMIN000018926
- Lead Sponsor
- Department of Urology and Andrology, Kansai Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 102
Inclusion Criteria
Not provided
Exclusion Criteria
1)Bone metastasis 2)Castration resistance prostate cancer 3)hypocalcaemia Ca<8mg/dl 4)Androgen deprivation therapy>1 yr and Young Adult Mean>90% 5)Prior treatment with a bisphosphonate, RANKL, parathyroid hormone 6)Prior treatment with a glucocorticoids 7)Under treatment of tooth 8)A history of achalasia 9)Estimated glomerular filtration rate <35 ml/min 10)Liver function tests>1.5 times the upper limit of normal 11)Bilateral hip replacement 12)A history of metabolic bone disease (Paget disease, hyperparathyroidism, osteomalacia, untreated hypothyroidism) 13) The patients should be excluded ,Who have poor medical compliance, drug-induced allergy, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage change in spine BMD
- Secondary Outcome Measures
Name Time Method The percentage change in total hip and femoral neck The percentage changes in bone markers of resorption and formation The incidence of skeletal-related event The incidence of adverse events in minodronate and denosumab treatment The Adherence of minodronate and denosumab The efficacy of each drug(the percentage change in BMD, The percentage changes in bone markers )