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Clodronate treatment of established bone loss in cardiac recipients: a randomized study
Giovanbattista Ippoliti1, Carlo Pellegrini, Carlo Campana
1Divisione di Medicina Interna, Ospedale Civile, Voghera, Pavia, Italy. giovanbattista_ippoliti@asl.pavia.it
Insights
Oral clodronate therapy significantly increased bone mineral density at the lumbar spine in heart transplant recipients. This treatment effectively prevented new bone fractures without impacting graft function.
Area of Science:
- Cardiology
- Orthopedics
- Pharmacology
Background:
- Bone loss and increased fracture risk are common complications following heart transplantation (HTx).
- Existing osteoporosis treatments yield variable results in HTx patients.
- This study investigates the efficacy of oral bisphosphonate therapy for post-HTx bone loss.
Purpose of the Study:
- To evaluate the effect of oral clodronate on bone mineral density (BMD) in heart transplant recipients.
- To assess the incidence of new bone fractures during treatment.
- To determine the safety and tolerability of clodronate in this patient population.
Main Methods:
- Sixty-four HTx patients with low BMD were randomized to receive oral clodronate or placebo for 12 months.
- All patients received calcium carbonate supplementation.
- BMD was measured using dual-energy x-ray absorptiometry; laboratory tests were conducted periodically.
Main Results:
- Patients exhibited significant bone loss 6 months post-HTx compared to controls.
- Clodronate therapy increased lumbar spine BMD by 11.7% (P=0.02) after 1 year.
- No new fractures occurred in the clodronate group versus 9.3% in the placebo group; therapy was well-tolerated.
Conclusions:
- One year of oral clodronate therapy significantly improves lumbar spine BMD in heart transplant patients.
- Clodronate effectively prevents new bone fractures in this cohort.
- The treatment is well-tolerated and does not compromise graft function.
Background:
Bone loss has been reported as a complication after heart transplantation (HTx), and the increase in bone fractures is an effective problem. Treatment of osteoporosis has obtained mixed results. In this study we evaluate the effect of treatment with an oral bisphosphonate.
Methods:
Sixty-four patients with low mineral density 6 months after HTx were randomized as follows: Group A received oral clodronate (1600 mg/day in two divided doses), and Group B received placebo. Every patient was also treated with 2000 mg/day of oral calcium carbonate. Bone mineral density (BMD) was measured by dual energy x-ray absorptiometry at the lumbar spine, 1/3 and 1/10 of the distal nondominant forearm before and after 12 months of treatment. Laboratory tests were performed at 3, 6, and 12 months of treatment.
Results:
All patients demonstrated manifest bone loss 6 months after HTx compared with normal non-HTx controls (P=0.0001). After 1 year of clodronate therapy, BMD at the lumbar spine increased from 0.77+/-1.4 g/cm(2) to 0.86 g/cm(2) (P=0.02). Laboratory tests did not show any significant variation, except for the bone isoenzyme of alkaline phosphatase, which showed a significant decrease after 1 year of treatment. The incidence of new fractures was 9.3% in the placebo group and 0% in the clodronate group. Therapy was well tolerated without impact on graft function.
Conclusions:
One year of clodronate therapy induced a significant increase in BMD at the lumbar spine in our HTx patients. Treatment was well tolerated without onset of new bone fractures.
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