NuvaRing does not affect bone mineral density in pre-menopausal women

NuvaRing does not affect bone mineral density in pre-menopausal women

R. Massai (1), L. Mäkäräinen (2), A. Kuukankorpi (3), C. Klipping (4), I.

Duijkers (4), T. Dieben (5)

Instituto Chileno de Medicina Reproductiva, Santiago, Chile (1);

Department of Obstetrics and Gynaecology, University of Oulu, Finland (2);

Family Planning Clinic, Tampere, Finland (3); Dinox Medical Investigations,

Nijmegen, The Netherlands (4); Clinical Development Department, NV Organon, Oss,

The Netherlands (5)

Introduction: In pre-menopausal women, hormonal contraceptives have

been associated with positive, neutral and even negative effects on bone mineral

density (BMD), differences that may be dose-dependent and/or age related in

nature. NuvaRing is a monthly combined contraceptive vaginal ring that releases

15 µg ethinylestradiol and 120 µg etonogestrel daily and has been shown to be

effective, well tolerated, convenient and highly acceptable to users. The

objective of this trial was to compare the effects of NuvaRing and non-hormonal

methods or no contraception on BMD in pre-menopausal women.

Design and methods: This was an open-label, multicentre trial in

healthy women (n=144; 18–35 years). Subjects were assigned 3:1 to NuvaRing

(n=105) and control groups (n=39). The control group consisted of women who did

not use a contraceptive method, those who chose to use or were already using a

non-hormonal intrauterine device (IUD), and those who wished to use a

non-hormonal contraceptive method other than the IUD. The NuvaRing group was

treated for 26 cycles, each of 4 weeks’ duration (3 weeks’ ring use, 1 week

ring-free), and the control group was treated for 24 months. Assessments of BMD

of the lumbar spine and proximal femur were made using dual-energy X-ray after

cycles 13 (month 12) and 26 (month 24).

Results: Of the 142 treated subjects, 27 in the NuvaRing group (26.2%)

and eight in the control group (20.5%) discontinued. The reasons for

discontinuation in the NuvaRing group were adverse events (15.5%) and ‘other

reasons’ (10.7%), such as a desire to become pregnant. In the control group,

two women using IUDs discontinued due to pregnancy (5.1%), two due to adverse

events (5.1%) and four for ‘other reasons’ (10.3%). No change in BMD was

observed in NuvaRing users (n=93) in the lumbar spine (Z-score change: 70.058

and 70.098) or femoral neck (70.057 and 70.061) from baseline to cycle 13 or 26,

respectively. In the control group (n=34), BMD increased slightly in both the

lumbar spine (0.212 and 0.257) and the femoral neck (0.085 and 0.223). The

between-group differences were statistically significant for the lumbar spine at

cycle 13/month 12 (p=0.003) and for both the lumbar spine and femoral neck at

cycle 26/month 24 (both p<0.0001). These differences were not considered clinically relevant. NuvaRing was generally well tolerated and no notable treatment differences in body weight were observed between the two groups.

Conclusions: Two years of NuvaRing use in healthy adult women had no

effect on BMD.

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