Trials / Completed
CompletedNCT00680953
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
A Randomized, Double-Blind, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of Denosumab in Japanese Osteoporotic Subjects With Prevalent Fragility Vertebral Fracture(s)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,262 (actual)
- Sponsor
- Daiichi Sankyo Co., Ltd. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the efficacy and safety of denosumab in the treatment of involutional (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral fracture(s)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denosumab | Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months). |
| DRUG | Placebo | Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months). |
| DRUG | Alendronate sodium hydrate | Oral tablet once a week for 24 months |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2012-06-01
- Completion
- 2012-07-01
- First posted
- 2008-05-20
- Last updated
- 2015-03-12
- Results posted
- 2014-02-26
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00680953. Inclusion in this directory is not an endorsement.