Trials / Completed
CompletedNCT02838121
Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy
Investigation on the Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy: A Prospective Randomized Clinical Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Mel Shiuann-Sheng Lee · Academic / Other
- Sex
- All
- Age
- 35 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy under mechanical unloading after THR implantation, further compromises the longevity of implant. The prospective randomized study is aimed to investigate the periprosthetic bone loss after primary total hip replacements.
Detailed description
This study is a prospective, randomized, open-label clinical trial. The study will be performed in patients after obtaining informed consent. Group assignment is by drawing a sealed envelops based on random table. (1) Group 1: Experimental group 30 cases, Aclasta® (Zoledronic acid 5mg/100ml) is given intravenously on the 4th postoperative day and one year after the total hip replacement, (2) Group 2: Control group, 30 cases, no bisphosphonate is given to the patients. Only the unilateral coxarthrosis will be recruited for the study. Patients will be analyzed with (1) DXA study (2) Clinical assessment (Harris hip score and SF-12) (3) X-ray (4) serum marker of bone turnover. Patients will be scheduled for specified examinations preoperatively, postoperatively 6 weeks, 3 months, 6 months, 12 months, and 24 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aclasta | Aclasta once annually for 2 years |
| DRUG | Placebo | No IV aclasta |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2013-01-01
- Completion
- 2016-06-01
- First posted
- 2016-07-20
- Last updated
- 2016-07-20
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT02838121. Inclusion in this directory is not an endorsement.