Abstract and Introduction
Background: The long-term effects of ossein-hydroxyapatite compound (OHC), a drug used for osteoporosis prevention, have not been previously reported. The aim of this study was to assess the long-term efficacy of OHC in postmenopausal women with bone mineral density (BMD) in the osteopenia range.
Methods: We performed a retrospective 4-year follow-up study in a primary-care setting to assess changes in BMD in a cohort of 112 postmenopausal women included in an osteoporosis programme that included health and dietary advice and who were treated with OHC 1660mg every 12 hours. BMD was measured annually in the distal part of the forearm, with T- and Z-score values being calculated for trabecular and total bone.
Results: A progressive and statistically significant increase in BMD was observed in trabecular and total T- and Z-score mean values. At baseline, mean ± SD trabecular T- and Z-scores were -1.27 ± 0.7 and -1.03 ± 0.7, respectively, and -0.86 ± 0.7 and -0.62 ± 0.7, respectively, at the end of the 4-year follow-up period (both p < 0.0001). Mild constipation was observed in 3.2% of patients during the follow-up period.
Conclusion: Ossein-hydroxyapatite compound could be an effective and safe agent for the prevention of bone loss in postmenopausal osteopenic women, with significant increases in BMD being observed in this group of patients.
The prevalence of osteoporosis in the Spanish female population, as in other European countries, is about 13%, but this percentage increases to 35% in women aged ≥50 years. Despite this high prevalence, the proportion of women receiving preventive treatment remains very low as osteoporosis is underdiagnosed and undertreated worldwide.[4,5,6,7,8]
There are several drugs that prevent bone mass loss and reduce the risk of fractures secondary to bone fragility, but it is important to choose the most appropriate treatment for each patient in order to obtain an acceptable risk/benefit ratio. Two studies carried out in young postmenopausal women treated with either vitamin D and calcium or alendronic acid showed significant bone mass loss in the placebo groups compared with actively treated groups, suggesting the value of preventive treatment in young postmenopausal women.
Ossein-hydroxyapatite compound (OHC) has shown efficacy, either as monotherapy or when combined with hormone replacement therapy (HRT), in maintaining bone mineral density (BMD) and preventing postmenopausal osteoporosis. OHC has also been shown to be effective in the prevention of corticosteroid-induced osteoporosis.[14,15] In these situations (postmenopausal osteoporosis and corticosteroid-induced osteoporosis), significant bone mass maintenance was observed in women treated with OHC, compared with bone mass loss observed in patients treated with calcium carbonate or in the control group. Moreover, an increase in BMD was obtained when OHC was used in combination with other drugs (e.g. HRT and vitamin D).
An 830mg tablet of OHC is made up of: calcium 178mg, phosphorus 82mg and bone metabolism proteins (osteocalcin 5.8μg; type I collagen 216mg; insulin-like growth factor I [IGF-I] 168ng; IGF-II 84ng; transforming growth factor β [TGF-β] 21ng). The organic components of OHC have been shown to have significant effects on bone regeneration in experimental studies, suggesting an osteogenic action.[16,17] Other studies suggest that OHC is able to stimulate bone metabolism, particularly when osteoblastic activity is reduced. This effect might be related to osteoblast stimulation and proliferation, in which growth factors such as TGF-β and IGF-I have been implicated.
Because of a lack of data about the long-term efficacy of OHC in preventing bone loss in postmenopausal women, the present retrospective study was carried out to investigate the progression of BMD over 4 years in a group of patients with a mean baseline BMD value within the osteopenic range who were treated with OHC. The subjects were participating in a menopause programme (see next section) conducted by a primary-care centre in Madrid.
Clin Drug Invest. 2007;27(4):227-232. © 2007 Adis Data Information BV
Cite this: Prevention of Osteoporosis - Medscape - Apr 01, 2007.