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Effect of Two Kinds of Different Combined Oral Contraceptives Use

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Effect of Two Kinds of Different Combined Oral Contraceptives Use Contraception 86 (2012) 332–336 Original research article Effect of two kinds of different combined oral contraceptives use on bone mineral density in adolescent women☆ ⁎ Ling Gaia, , Yifang Jiab, Meihua Zhanga, Ping Gaib, Sumei Wanga, Hong Shia, Xiaojie Yua, Yonghong Liuc aKey Laboratory for Improving Birth Outcome Technique, Shandong Provincial Institute of Science and Technology for Family Planning, Jinan, Shandong 250002, China bProvincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China cShandong Medical Imaging Research Institute, Jinan, Shandong 250021, China Received 26 December 2011; revised 16 January 2012; accepted 18 January 2012 Abstract Background: Steroid hormonal contraceptives are highly effective and widely used. Most studies have shown a negative effect of combined oral contraceptives (COCs) on the bone mineral density (BMD) of adolescents. The study was conducted to compare BMD among users of ethinylestradiol/desogestrel, users of ethinylestradiol/cyproterone acetate and nonhormonal control subjects in women aged 16–18 years. Study Design: The study included 450 women 16–18 years of age. One hundred fifty women were using ethinylestradiol/desogestrel, 150 women were using ethinylestradiol/cyproterone acetate, and 150 women were using nonhormonal contraception as control subjects. BMD of the lumbar spine and femoral neck was obtained using dual-energy X-ray absorptiometry, and mean BMD changes in COCs users and nonusers were compared. Results: At 24 months of treatment, lumbar spine and femoral neck mean BMD values in women (n=127) who used ethinylestradiol/ desogestrel were slightly lower compared with baseline, but these effects did not reach statistical significance (p=.837 and p=.630, respectively). The mean lumbar spine and femoral neck BMD values in women (n=134) who used ethinylestradiol/cyproterone acetate were slightly higher compared with baseline, but there was no statistical significance (p=.789 and p=.756, respectively). The increases in mean percent change in lumbar spine and femoral neck BMD in the ethinylestradiol/cyproterone acetate group were less than those in the control group (1.88% vs. 0.30% and 0.98% vs. 0.49%, respectively). There were no significant differences in mean BMD of the lumbar spine and femoral neck between the users of ethinylestradiol/desogestrel or ethinylestradiol/cyproterone acetate and nonusers (pN.05). Conclusion: Our study indicates that 2 years of COCs therapy had no significant effect on bone density in adolescents, but it remains unknown whether therapy longer than 2 years has a significant adverse effect on the attainment of peak bone mass. © 2012 Elsevier Inc. All rights reserved. Keywords: Combined oral contraceptive (COCs); Ethinylestradiol/desogestrel; Ethinylestradiol/cyproterone acetate; Bone mineral density (BMD); Contraception 1. Introduction Steroid hormonal contraceptives, including oral and in- jectable contraceptives, are highly effective and widely used. These contraceptives have important health benefits, includ- ☆ This study was supported by a grant from the Research Foundation of ing contraceptive and noncontraceptive benefits, but also the Shandong Provincial Committee of Family Planning Research, Jinan, have some health risks, such as bone health. Some studies Shandong, China. have demonstrated that use of progestin-only contraceptive ⁎ Corresponding author. Key Laboratory for Improving Birth Outcome depot medroxyprogesterone acetate (DMPA) may cause Technique, Shandong Provincial Institute of Science and Technology for Family Planning, Jinan, Shandong 250002, China. Tel.: +86 531 82597813; bone loss [1,2]. Combined oral contraceptives (COCs) may fax: +86 531 82597807. also adversely affect bone health, especially when used in E-mail address: [email protected] (L. Gai). adolescents [3] and young women [4]. Use of COCs may 0010-7824/$ – see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2012.01.009 L. Gai et al. / Contraception 86 (2012) 332–336 333 impede attainment of peak bone mass [4]. Most COCs users baseline. All subjects had BMD determined approxi- are under 30 years of age [5]. Previous investigations have mately every 12 months for 24 months. The data were sta- examined the effect of COCs on bone mineral density tistically analyzed. (BMD) in adolescents [3–9], but the results are inconsistent. The objective of the present study was to evaluate 2.3. Statistical analysis whether use of ethinylestradiol (EE)/desogestrel and EE/ All analyses were performed using SPSS version 13.0. cyproterone acetate affects bone health in adolescent women The one-way analysis of variance was used to test for dif- by comparing their BMDs with those of controls. ferences of BMD values and selected characteristics among the three groups, and two-group comparisons for these vari- ables were conducted using t tests. A statistical test with a 2. Materials and methods p valueb.05 was considered statistically significant. Data 2.1. Subjects are presented as mean±SD. We originally enrolled 450 women from 16 to 18 years old attending family planning clinics and requesting birth 3. Results control. All of these women had never used hormonal con- 3.1. Demographic and anthropometric characteristics traception prior to recruitment to this study. Three hundred women requesting COCs contraception were randomized In total, 450 women aged 16–18 years were recruited. A into two treatment groups by drawing lots, receiving either total of 138 (92.0%) EE/desogestrel users, 139 (92.7%) EE/ an EE/desogestrel oral contraceptive with EE 30 mcg and cyproterone acetate users and 136 (90.7%) nonhormonal desogestrel 0.15 mg (N.V. Organon, the Netherlands) (group users completed the first 12 months of observation, and a A, n=150) or EE/cyproterone acetate oral contraceptives total of 127 (84.7%) women in the EE/desogestrel group, with EE 35 mcg and cyproterone acetate 2 mg (Schering 134 (89.3%) women in EE/cyproterone acetate group and GmbH and Co., Germany) (group B, n=150). Women of 115 (76.7%) women in the nonhormonal group completed groups A and B were instructed to start pill intake from the the entire 24 months of observation. The reasons for fifth day after the beginning of the next spontaneous menses treatment-phase withdrawal (n=23) in group A were as for 21 days with a 7-day pill-free interval. Women who did follows: nine (39.1%) women terminated for side effects of not wish to use hormonal birth control were recruited as the method, such as irregular bleeding, nausea, etc.; three nonhormonal controls (group C, n=150). They used intra- (13.0%) became pregnant; five (21.7%) moved; four (17.4%) uterine device or condom for contraception. were noncompliant; and two (8.7%) were lost to follow-up. Inclusion and exclusion criteria include the following: All The reasons for treatment-phase withdrawal (n=16) in group subjects had regular menses, should not have used any kind B were as follows: two (12.5%) had irregular bleeding, two of hormonal contraception, and had no breastfeeding or (12.5%) became pregnant, three (18.8%) moved, six (37.5%) delivery for at least 6 months. They were also required not to were noncompliant, and three (18.8%) were lost to follow- become pregnant. They did not take any calcium, vitamin D up. The reasons for treatment-phase withdrawal (n=35) in and bone-affecting medication. Women who had chronic group C were as follows: 22 (62.9%) became pregnant, 6 disease, such as diabetes mellitus, renal dysfunction, thyroid (17.1%) moved, 3 (8.6%) were noncompliant, and 4 (11.4%) and parathyroid diseases, hepatitis or pituitary diseases, were were lost to follow-up. excluded from this study. Written informed consent was Table 1 shows baseline information about these women. obtained from subjects and their parents or legal guardians There were no significant differences between the three when the subjects were under the age of 18 years. Study contraceptive user groups regarding mean age, BMI, age at protocols were approved by the Institutional Review Board of menarche, menstrual cycle or number of pregnancies. Shandong Provincial Institute of Family Planning Research. 3.2. BMD measurements 2.2. Variables There were no significant differences in lumbar spine and The subjects were asked about their age, number of femoral neck mean BMD among groups A, B and C at pregnancies and deliveries, menstrual status, etc. Physical baseline. At 24 months of treatment, in group A, as compared measurements were carried out for their height and weight. to baseline, the mean BMD in lumbar spine and femoral neck Height was measured using a stadiometer. Body weight was revealed a slight decrease. The mean percentage change from measured with calibrated electronic scales. Body mass index baseline in lumbar spine and femoral neck had decreased by (BMI) was calculated as body mass/(height)2. 0.30% and 0.61%, respectively. The mean lumbar spine and BMD at the lumbar spine (L2-4) and femoral neck was femoral neck BMD values at 24 months were not signi- measured by dual-energy X-ray absorptiometry (QDR- ficantly different compared to baseline and subjects in the 4500W, Hologic, Bedford, MA, USA). Results were recorded nonuser group (pN.05). While in groups B and C, there was a as g/cm2. Before using COCs, BMD was determined at trend toward increasing BMD. In group B, the mean 334 L. Gai et al. / Contraception 86 (2012) 332–336 Table 1 adolescents (14–18 years), mean BMD did not differ by Demographic and anthropometric characteristics of the participants COCs duration of use or EE dose. However, in women aged Group A Group B Group C p value between 19 and 30 years, the mean BMD was lower with N 150 150 150 longer COCs use for the spine and whole body (p=.004 and Chronological age 17.09±0.79 17.05±0.78 17.13±0.78 .718 .02, respectively) and lowest for N12 months of low-dose (years) COCs for the hip, spine and whole body (p=.02, .003 and Gynecologic age (years) 3.72±1.22 3.65±1.20 3.72±1.32 .867 .002, respectively).
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