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.
Department of Internal Med. IV, Klinikum Leverkusen, Teaching Hospital of the University of Cologne, Germany. ringe@klinikum-lev.de
Johann Diederich
JD
Ringe
Ivo
I
Setnikar
D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D001416:Back Pain / Q000188:drug therapy / Q000517:prevention & control; D015519:Bone Density / Q000187:drug effects / Q000502:physiology; D001842:Bone and Bones / Q000187:drug effects* / Q000378:metabolism / Q000503:physiopathology; D002118:Calcium / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D015914:Estrogen Replacement Therapy / Q000009:adverse effects*; D004967:Estrogens / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005459:Fluorides / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D010710:Phosphates / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D016103:Spinal Fractures / Q000188:drug therapy / Q000517:prevention & control; D016896:Treatment Outcome
D000700:Analgesics; D004967:Estrogens; D010710:Phosphates; C012980:fluorophosphate; D005459:Fluorides; D002118:Calcium