Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients
Phase 2
Recruiting
- Conditions
- Osteoporosis
- Interventions
- Drug: SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug"Drug: Bisphosphonates and ELD "Edirol®Tablet 0.75ug"Drug: ELD "Edirol®Tablet 0.75ug"
- Registration Number
- NCT03755193
- Lead Sponsor
- Shinshu University
- Brief Summary
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in Japanese osteoporosis patients after 2-year-denosumab therapy:
SERM and eldecalcitol treatment for 24 months Bisphosphonates and eldecalcitol treatment for 24 months Eldecalcitol treatment for 24 months
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- osteoporosis patients
Exclusion Criteria
- not osteoporosis patients who are allergic to the drugs, refused to do this research, or who are pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SERM plus ELD SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug" To examine the effects of SERM plus ELD in osteoporosis patients SERM plus ELD ELD "Edirol®Tablet 0.75ug" To examine the effects of SERM plus ELD in osteoporosis patients BP plus ELD SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug" To examine the effects of BP plus ELD in osteoporosis patients BP plus ELD Bisphosphonates and ELD "Edirol®Tablet 0.75ug" To examine the effects of BP plus ELD in osteoporosis patients BP plus ELD ELD "Edirol®Tablet 0.75ug" To examine the effects of BP plus ELD in osteoporosis patients ELD alone SERM "Viviant®Tablet 20mg" and ELD "Edirol®Tablet 0.75ug" To examine the effects of ELD alone in osteoporosis patients ELD alone Bisphosphonates and ELD "Edirol®Tablet 0.75ug" To examine the effects of ELD alone in osteoporosis patients ELD alone ELD "Edirol®Tablet 0.75ug" To examine the effects of ELD alone in osteoporosis patients SERM plus ELD Bisphosphonates and ELD "Edirol®Tablet 0.75ug" To examine the effects of SERM plus ELD in osteoporosis patients
- Primary Outcome Measures
Name Time Method Assessment of bone mineral density in osteoporosis patients treated by SERM plus ELD, Bisphosphonate plus ELD, or ELD alone Change from Baseline Values of bone mineral density at 2 years in each group
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Yukio Nakamura
🇯🇵Matsumoto, Nagano, Japan