Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study.
Study Goal
The researchers aimed to evaluate the adherence, safety, and tolerability of calcium citrate supplementation in elderly osteopenic subjects.
Results Summary
The study found favorable adherence (76.6%) to calcium citrate supplementation, with mild adverse reactions (3.9%) primarily gastrointestinal. Lower adherence was associated with higher adverse event frequency. Both systolic and diastolic blood pressure decreased significantly from baseline.
Population
Elderly osteopenic subjects (91.4% female, mean age 70 ± 4.5 years).
Effective Dosage
500 mg calcium citrate daily.
Duration
Up to one year.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
calcium citrate supplementation | increase | bone health | elderly | - | plays a crucial role in improving | #1 |
calcium citrate supplementation | decrease | fracture risk | elderly | - | reducing | #2 |
calcium citrate supplementation | increase | overall skeletal strength | elderly | - | supporting | #3 |
calcium citrate supplementation | increase | adherence | elderly osteopenic subjects | - | demonstrated favorable adherence to | #4 |
calcium citrate supplementation | neutral | adherence | elderly osteopenic subjects | 76.6 ± 29.5% | Mean adherence to treatment was | #5 |
calcium citrate supplementation | neutral | adherence | elderly osteopenic subjects | 91% | half of subjects had an adherence of | #6 |
calcium citrate supplementation | neutral | adherence | elderly osteopenic subjects | 100% | ~ 33% of participants achieved complete | #7 |
calcium citrate supplementation | neutral | adverse reactions | elderly osteopenic subjects | nine (3.9%) subjects | ARs were reported by | #8 |
calcium citrate supplementation | increase | adverse events | elderly osteopenic subjects with adherence < 80% | 41.6% (32/77) | The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of < 80% | #9 |
calcium citrate supplementation | increase | adverse events | elderly osteopenic subjects with adherence ≥ 80% | 11% (16/145) | The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of ≥ 80% | #10 |
calcium citrate supplementation | decrease | systolic blood pressure | elderly osteopenic subjects | -2.8 ± 13.9 mmHg | systolic blood pressure decreased from baseline to follow-up visit | #11 |
calcium citrate supplementation | decrease | diastolic blood pressure | elderly osteopenic subjects | -2.1 ± 10.4 mmHg | diastolic blood pressure decreased from baseline to follow-up visit | #12 |
calcium citrate supplementation | decrease | adherence | elderly osteopenic subjects | - | The occurrence of ARs, though generally mild, were associated with lower adherence to | #13 |
BACKGROUND: Osteoporosis is a common concern in the elderly that leads to fragile bones. Calcium supplementation plays a crucial role in improving bone health, reducing fracture risk, and supporting overall skeletal strength in this vulnerable population. However, there is conflicting evidence on the safety of calcium supplements in elderly individuals. AIM: The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects. METHODS: In this non-interventional, prospective, multicenter study, subjects received daily 500 mg calcium citrate supplementation for up to one year. Adherence was calculated based on compliance and persistence. Safety was assessed through adverse reactions (ARs), deaths, and clinical laboratory evaluations. RESULTS: A total of 268 Caucasian subjects (91.4% female, mean age 70 ± 4.5 years) participated in the study. Mean adherence to treatment was 76.6 ± 29.5% and half of subjects had an adherence of 91% and ~ 33% of participants achieved complete (100%) adherence. ARs were reported by nine (3.9%) subjects, primarily gastrointestinal disorders, with no serious ARs. The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of < 80% (41.6%; 32/77) vs. those with adherence ≥ 80% (11%; 16/145, p < 0.0001). Both systolic and diastolic blood pressure decreased from baseline to follow-up visit (change of -2.8 ± 13.9 mmHg, p = 0.0102 and -2.1 ± 10.4 mmHg, p = 0.0116, respectively). CONCLUSION: This study demonstrated favorable adherence to calcium citrate supplementation in elderly osteopenic subjects. The occurrence of ARs, though generally mild, were associated with lower adherence to calcium supplementation.