Prediabetic, postmenopausal women with osteopenia who took alendronate (Fosomax®) for 12 weeks had no statistically significant differences in serum lipid profiles compared with placebo, according to a study in the Journal of Research in Medical Sciences.
The triple‑blind, randomized controlled trial included women aged 45 to 60 years with prediabetes as defined by American Diabetes Association’s 2017 criteria. Osteopenia was based on a T score between −1.5 and −2.4 bone density measured by a Hologic device.
Sixty women were randomly assigned to 1 of 2 groups—the intervention group (n=30) received a 70‑mg weekly dose of alendronate, and the control group (n=30) received a placebo. The medication was taken weekly for 12 weeks. The primary outcome was lipid profile, which was assessed before and after the intervention.
Women in the alendronate group had a mean (SD) age of 56.5 (6.3) years and a mean body mass index (BMI) of 26.6 (3.1) kg/m2. Women in the placebo group had a mean (SD) age of 55.3 (4.0) years and a mean BMI of 26.0 (3.0) kg/m2.
No significant differences were observed at baseline between the 2 groups in 25(OH) D3 (P = .435) and serum lipids, triglyceride (TG) (P = .906), cholesterol (P = .813), low‑density lipoprotein cholesterol (LDL‑C) (P = .347), and high‑density lipoprotein cholesterol (HDL‑C) (P = .650) concentrations.
After intervention, the changes were not significantly different between the alendronate and placebo groups for 25(OH) D3 concentration (P = .567), serum lipids, TG (P = .826), cholesterol (P = .415), LDL‑C (P = .268), and HDL‑C (P = .794) concentration, according to the Greenhouse–Geisser test. No significant changes were detected in either group regarding 25(OH) D3 and lipid profile concentration (P > .05). Insulin resistance showed improvement in the alendronate group, according to the researchers.
Mean levels of lipid profiles were not significantly different between the alendronate and placebo groups at the end of the 12-week study period when baseline values (all P > .05) and potential confounders such as age, sex, BMI, and waist circumference were adjusted.
The researchers acknowledged several limitations of their study. It was short in duration and underpowered for all primary outcomes. Additionally, the study population was heterogeneous, as women recruited from those who visited the Isfahan Endocrine and Metabolism Research Center between March 16 and December 16, with a long duration of osteopenia.. More studies with larger sample sized and longer drug intervention periods are needed.
“The administration of alendronate for 12 weeks improved insulin resistance in these women; however, it had no effect on the lipid profile,” stated the study authors. “The improvement in insulin resistance can decrease the proportion of small dense lipoprotein and lower atherogenic lipid, although there are no changes in lipid profile.”
Karimifard M, Aminorroaya A, Amini M, et al. The effect of alendronate on lipid profile of postmenopausal women with osteopenia and prediabetes: a randomized triple‑blind clinical trial. J Res Med Sci. 2021;26:52. doi: 10.4103/jrms.JRMS_579_19. eCollection 2021