The concern with SR-NaF is that only one placebo-controlled randomized trial had been completed. Other forms of fluoride have already been approved in 14 foreign countries. Conventional fluoride has already been shown to be efficacious in inhibiting spinal fractures. SR-NaF has been found to be even more effective in averting spinal fractures than conventional preparations. This finding has been supported by open trials in objective comparison at the same strata of baseline L2-L4 BMD. The main issue with fluoride is its safety. With SR-NaF, skeletal fluoride was kept below the toxic threshold, and structural integrity and improved quality of bone were demonstrated. Safety of SR-NaF was shown in 507 patients who were followed over 1325 patient-years. No patient developed gastric ulcers. Microfractures developed only in steroid-treated patients. The hip fracture rate was comparable to that of normal postmenopausal women and less than that of untreated patients with postmenopausal osteoporosis or those treated with plain NaF. Minor side effects were the same as in the placebo-treated group. Finally, the indication of SR-NaF is for treatment of established postmenopausal osteoporosis with prevalent fractures. Although only one randomized trial has been completed, the results convincingly showed both efficacy and safety of SR-NaF. The treatment is particularly effective in patients with mild- moderate bone loss. A less marked response in those with severe disease emphasizes the need for early intervention.
|Original language||English (US)|
|Number of pages||4|
|Journal||Journal of Bone and Mineral Research|
|State||Published - May 1 1996|
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism
- Orthopedics and Sports Medicine