N B Srividhya1, Nilanchali Singh2, Neerja Goel1, J K Gambhir3, Vinita Rathi4, Shalini Rajaram1. 1. Department of Obstetrics and Gynaecology, University College of Medical Sciences & Guru Tegh Bahadur Hospital, New Delhi, India. 2. Department of Obstetrics and Gynaecology, University College of Medical Sciences & Guru Tegh Bahadur Hospital, New Delhi, India nilanchalisingh@gmail.com. 3. Department of Biochemistry, University College of Medical Sciences, New Delhi, India. 4. Department of Radiology, University College of Medical Sciences, New Delhi, India.
Abstract
OBJECTIVES: The aim of this study is to compare the antiresorptive effect of hormone therapy and oral ibandronate in postmenopausal osteoporotic women by measuring bone mineral density (BMD) and degradation products of C-terminal telopeptide of type I collagen (CTX) using serum crosslaps ELISA. STUDY DESIGN: The study is a randomized comparative trial. METHODS: About 60 women with age > 40 years, having either surgical or medical menopause with T- or Z-score below -2.5 SD were included in the study. They were randomized into two groups of 30 each; one group received conventional hormone therapy (group I) and the other group received ibandronate monthly (group II). The treatment was given for 6 months. RESULTS: The BMD increased from 0.894 g/cm(2) to 0.933 g/cm(2) (p < 0.01) in group I and from 0.865 g/cm(2) to 0.934 g/cm(2) (p < 0.01) in group II. The increase in BMD in group I (4.3%) was less than group II (7.9%) which was significant (p < 0.01). The serum CTX levels also showed significant reduction in both groups after 6 months of therapy; more reduction was seen in group II as compared to group I (41.5% vs. 4.6%, p < 0.01). CONCLUSION: Ibandronate can be used as a substitute to hormone therapy in women presenting with osteoporosis. Long-term studies are needed to authenticate the observation.
RCT Entities:
OBJECTIVES: The aim of this study is to compare the antiresorptive effect of hormone therapy and oral ibandronate in postmenopausal osteoporoticwomen by measuring bone mineral density (BMD) and degradation products of C-terminal telopeptide of type I collagen (CTX) using serum crosslaps ELISA. STUDY DESIGN: The study is a randomized comparative trial. METHODS: About 60 women with age > 40 years, having either surgical or medical menopause with T- or Z-score below -2.5 SD were included in the study. They were randomized into two groups of 30 each; one group received conventional hormone therapy (group I) and the other group received ibandronate monthly (group II). The treatment was given for 6 months. RESULTS: The BMD increased from 0.894 g/cm(2) to 0.933 g/cm(2) (p < 0.01) in group I and from 0.865 g/cm(2) to 0.934 g/cm(2) (p < 0.01) in group II. The increase in BMD in group I (4.3%) was less than group II (7.9%) which was significant (p < 0.01). The serum CTX levels also showed significant reduction in both groups after 6 months of therapy; more reduction was seen in group II as compared to group I (41.5% vs. 4.6%, p < 0.01). CONCLUSION:Ibandronate can be used as a substitute to hormone therapy in women presenting with osteoporosis. Long-term studies are needed to authenticate the observation.