Monofluorophosphate combined with hormone replacement therapy in postmenopausal osteoporosis. An open-label pilot efficacy and safety study.

A 3-year, open-label, monocenter study was performed on 60 patients with postmenopausal established osteoporosis treated with monofluorophosphate and calcium supplement (MFP/Ca) combined with hormone replacement therapy (HRT). Bone mineral density (BMD) after 3 years increased by 15.5% in the lumbar spine (L2-L4) and by 2.3% in the femur neck. During the 3 years, a total of six new vertebral fractures (NewVF) occurred in five patients (8.3% incidence) and a total of six nonvertebral fractures (Non-VF) occurred in six patients (10% incidence). Back pain score already decreased significantly after 6 months of treatment and, at the end of the 3rd treatment year, the pain score had decreased by 84%. The treatment was well tolerated, with only few mild or moderate adverse events. The results were compared with those of a previous study conducted in the same center with a similar protocol with a calcium supplement on patients suffering from postmenopausal established osteoporosis and treated with MFP/Ca but without HRT. It could be inferred that with the 3-year treatment, the combination of MFP/Ca with HRT protects from NewVF in one patient of every two treated. The comparison suggests that the MFP/Ca with HRT combination could be more effective than MFP/Ca alone in protecting from NewVF and from Non-VF, justifying further double blind, prospective randomized studies pursuing this investigation.