Intravenous ibandronate or sodium-fluoride--a 3.5 years study on bone density and fractures in Crohn's disease
Jochen Klaus1, Max Reinshagen, Katharina Herdt
1University of Ulm, Department of Internal Medicine I, 89081 Ulm, Germany. jochen.klaus@uniklinik-ulm.de
Insights
This study found that both sodium-fluoride and intravenous ibandronate effectively improved osteoporosis in Crohn's disease patients over 3.5 years. Intravenous bisphosphonates offer a safe and viable treatment option for these patients.
Area of Science:
- Bone Metabolism and Endocrinology
- Gastroenterology and Inflammatory Bowel Disease
- Pharmacology and Therapeutics
Background:
- Osteoporosis is a prevalent complication in Crohn's disease (CD) patients.
- Current management strategies for osteoporosis in CD have limitations, particularly with long-term efficacy of intravenous bisphosphonates.
- Intravenous bisphosphonates present an alternative for CD patients due to bypassing gastrointestinal irritation.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of colecalciferol with sodium-fluoride versus intravenous ibandronate for treating osteoporosis in Crohn's disease patients.
- To compare bone mineral density changes and fracture incidence between the two treatment groups.
Main Methods:
- A randomized trial involving 66 CD patients with lumbar osteoporosis (T-score < -2.5).
- Group A received colecalciferol, calcium-citrate, and sustained-release sodium-fluoride.
- Group B received intravenous ibandronate (1 mg every 3 months). Bone mineral density was assessed using DXA, and fractures were evaluated via X-rays over 3.5 years.
Main Results:
- Both treatment groups showed significant improvements in lumbar T-scores over the follow-up period (up to 3.5 years).
- Lumbar T-scores increased significantly in both Group A (sodium-fluoride) and Group B (ibandronate) from baseline.
- The study medication was well-tolerated, with no significant safety concerns reported. The study was not powered to detect differences in fracture rates.
Conclusions:
- Both sodium-fluoride and intravenous ibandronate treatments led to improvements in osteoporosis among Crohn's disease patients.
- Intravenous ibandronate is a safe and effective treatment option for osteoporosis in CD patients.
- Further research is needed to establish fracture reduction data for sodium-fluoride in this population.
Background And Aim:
Osteoporosis commonly afflicts Crohn's disease (CD) patients. Management remains unclear, with limited results for intravenous (i.v.) bisphosphonates and a follow-up longer than one year. Intravenous bisphosphonates bypass gastrointestinal-tract irritation offering an interesting alternative suitable for CD patients. We tested the long-term efficacy and safety of colecalciferol and calcium with sodium-fluoride or i.v. ibandronate for osteoporosis in CD.
Methods:
66 CD patients with lumbar osteoporosis (T-score<-2.5) were randomized to receive colecalciferol (1000 IU), calcium-citrate (800 mg) and intermittent sustained-release sodium-fluoride (50 mg) [groupA, n=33] or i.v. ibandronate (1 mg/3-monthly) [groupB, n=33]. Dual-energy X-ray absorptiometry of the lumbar-spine and right femur and X-rays of the spine were performed at baseline and after 1.0, 2.25 and 3.5 years. Fracture-assessment included visual reading and quantitative morphometry of X-rays.
Results:
55 (83.3%) patients completed at least the 1st year available for intention-to-treat (ITT) analysis, 42 (63.6%) completed the 2nd and 35 (53.0%) the 3rd year available for per-protocol analysis. Lumbar T-score increased by +0.23±0.43 (95%CI: 0.057-0.407, p<0.05), +0.71±1.05 (95%CI: 0.193-1.232, p<0.001) and +0.73±0.82 (95%CI: 0.340-1.336, p<0.001) (group A), and +0.28±0.41 (95%CI: 0.132-0.459, p<0.05), +0.43±0.55 (95%CI: 0.184-0.671, p<0.01) and +0.51±0.74 (95%CI: 0.145-0.882, p<0.001) (group B) during 1.0, 2.25 and 3.5 years follow-up time. In 2.71 years of follow-up, with the ITT analysis, the lumbar T-score increased by +0.66±0.97 (group A, p<0.001) and +0.46±0.67 (group B, p<0.001). One vertebral fracture with sodium-fluoride was not enough to detect differences between groups and the study was not powered for this. Study medication was well-tolerated and safe.
Conclusions:
Sodium-fluoride and i.v. ibandronate improved osteoporosis. Keeping in mind bisphosphonates as a standard of osteoporosis care that reduce fracture-rate, data we do not have for sodium-fluoride, CD patients with osteoporosis can be treated safely with i.v. ibandronate.
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