Janet Gersten1, Jennifer Hsieh2, Herman Weiss3, Nancy A Ricciotti4. 1. New Age Medical Research Corporation, Miami, Florida. Electronic address: jkgersten@gmail.com. 2. Teva Branded Pharmaceutical Products R&D, Inc, West Chester, Pennsylvania. 3. Teva Global Medical Affairs, Petach Tikva, Israel. 4. Teva Branded Pharmaceutical Products R&D, Inc, Frazer, Pennsylvania.
Abstract
STUDY OBJECTIVE: To compare changes in lumbar spine bone mineral density after 12 months of a 91-day extended regimen or 28-day combined oral contraceptive with those in a healthy reference group not using hormonal contraceptives. DESIGN: Phase 2, multicenter, open-label, randomized, controlled study. SETTING: Forty-five academic centers, clinical research centers, and community practices in the United States. PARTICIPANTS: Eight hundred twenty-nine postmenarcheal adolescent girls aged 12-18 years. INTERVENTIONS:Adolescents were randomly assigned to 91-day levonorgestrel (LNG)/ethinyl estradiol (EE) extended regimen (84 days of LNG 150 μg/EE 30 μg with 7 days of EE 10 μg [LNG/EE extended regimen]) or 28 days of LNG/EE (21 days of LNG 100 μg/EE 20 μg with 7 days of placebo [LNG/EE 21/7]) for 12 months. A reference group not seeking hormonal contraception was also evaluated. MAIN OUTCOME MEASURES: The primary end point was mean percent change in lumbar spine bone mineral density measured using dual-energy x-ray absorptiometry. RESULTS: Of 1361 adolescents randomized/enrolled, 829 were included in the primary analysis. Mean changes in lumbar spine bone mineral density were +2.26% with LNG/EE extended regimen, +1.45% with LNG/EE 21/7, and +2.50% in the reference group. Noninferiority of the LNG/EE extended regimen compared with the reference group was shown. A statistically significant treatment difference was found between LNG/EE 21/7 and the reference group (1.05%; 95% confidence interval, 0.61%-1.49%) but not between LNG/EE extended regimen and the reference group (0.23%; 95% confidence interval, -0.20% to 0.67%). No new safety signals were noted. CONCLUSION: Compared with the reference group, bone accrual was statistically significantly lower among LNG/EE 21/7 users but not among LNG/EE 30-μg extended regimen users. Additional research is needed to clarify the clinical relevance of these findings.
RCT Entities:
STUDY OBJECTIVE: To compare changes in lumbar spine bone mineral density after 12 months of a 91-day extended regimen or 28-day combined oral contraceptive with those in a healthy reference group not using hormonal contraceptives. DESIGN: Phase 2, multicenter, open-label, randomized, controlled study. SETTING: Forty-five academic centers, clinical research centers, and community practices in the United States. PARTICIPANTS: Eight hundred twenty-nine postmenarcheal adolescent girls aged 12-18 years. INTERVENTIONS: Adolescents were randomly assigned to 91-day levonorgestrel (LNG)/ethinyl estradiol (EE) extended regimen (84 days of LNG 150 μg/EE 30 μg with 7 days of EE 10 μg [LNG/EE extended regimen]) or 28 days of LNG/EE (21 days of LNG 100 μg/EE 20 μg with 7 days of placebo [LNG/EE 21/7]) for 12 months. A reference group not seeking hormonal contraception was also evaluated. MAIN OUTCOME MEASURES: The primary end point was mean percent change in lumbar spine bone mineral density measured using dual-energy x-ray absorptiometry. RESULTS: Of 1361 adolescents randomized/enrolled, 829 were included in the primary analysis. Mean changes in lumbar spine bone mineral density were +2.26% with LNG/EE extended regimen, +1.45% with LNG/EE 21/7, and +2.50% in the reference group. Noninferiority of the LNG/EE extended regimen compared with the reference group was shown. A statistically significant treatment difference was found between LNG/EE 21/7 and the reference group (1.05%; 95% confidence interval, 0.61%-1.49%) but not between LNG/EE extended regimen and the reference group (0.23%; 95% confidence interval, -0.20% to 0.67%). No new safety signals were noted. CONCLUSION: Compared with the reference group, bone accrual was statistically significantly lower among LNG/EE 21/7 users but not among LNG/EE 30-μg extended regimen users. Additional research is needed to clarify the clinical relevance of these findings.
Authors: Hawley C Almstedt; Makenzie M Cook; Lily F Bramble; Deepa V Dabir; Joseph W LaBrie Journal: J Bone Miner Metab Date: 2020-01-25 Impact factor: 2.626
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Authors: Tatjana S Brajic; Azita Goshtasebi; Tamara B L Goldberg; Abbey B Berenson; Jerilynn C Prior Journal: CMAJ Date: 2021-12-20 Impact factor: 8.262